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BWG Phase Two Results - Webinar

Discussion in 'Media, Interviews, Blogs, Talks, Events about XMRV' started by jspotila, Dec 11, 2010.

  1. urbantravels

    urbantravels disjecta membra

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    I think what we can conclude from the existence of the webinar is that we are getting a great opportunity to see the *entire* presentation - and ask questions - that we otherwise would not have had. Of course we're going to hear the main bullet points from whatever gets discussed in the FDA meeting, which is public (I very much hope some knowledgeable members of the press will be present to report on it) but without physically being in the room we won't hear the whole presentation. Are you saying that that there's no point to the webinar even happening if it doesn't represent the first announcement of previously-embargoed information?

    I think if we're expecting this coming week to settle all questions forever then we're aiming way too high and setting ourselves up for disappointment. Remember that what the BWG is doing is very complex, involves multiple centers and players, and is being carried out at a rather furious pace, as these things go. That they fell behind by a month is not surprising. I'm only surprised they didn't fall further behind (or perhaps they did and that's what we'll hear on the 14th.)

    I find that when I get too obsessive about wanting new information NOW NOW NOW, that is an excellent time to step away from the computer (or roll over, as the case may be) and turn my attention to something else for a little while. And BREATHE.
     
  2. George

    George waitin' fer rabbits

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    Hey ya Mark

    I don't think this a free at last situation(????) This is just another increment in the long process. The FDA will take recommendations on whither or not ME/CFS patients and Prostate Cancer Patients should be banned from donating blood and if a question should be added to screen out those patients. My guess is they will "take everything under advisement" and release a statement later like a couple of weeks into the new year.

    I'm not sure that they have enough information to ban us but a permanent deferral is most likely to be recommended until "further information is available".

    I think the problem will be that it is inconclusive that the virus is pathogenic, it is linked yes, but causal - not enough information at this time.

    During the testimony part the BWG will discuss what the problems with finding the virus and how to go about finding the virus correctly. I think we already have most of that information from our Spanish Friends. The need to look at the B cells, The best proteins to look for and correct handling of blood samples. The results of the testing won't have any bearing on number of people infected or percentages or anything of that nature. Each of the labs received X number of positive samples and X number of negative samples and using these assays this lab got an A+ and got all of the positives and negatives correct, lab 2 got this many right, and so on and so forth.

    The Webinar will just be for the science geeks who want to know the hows, and processes and stuff like that.

    Hold on a sec. . . (shaking majic 8 ball)

    Oh yeah, I figure we will see a new NIH web site with a bundle of information from all of the old PubMed studies that have been done over the years, Just after the first of the year.

    The April Workshop will most likely see a "link" proven but honestly by the time they get to the workshop we will probably have read all the papers anyway.

    Meanwhile people like our Spanish Friends will flesh out a good set of biomarkers and start working on how to . . . treat the immune problems and the sleep problems and all the other problems.

    (shake, shake, shake)

    By next September's 2nd annual conference there will be papers establishing the pathogenesis which will coincide with the beginning of drug development and an FDA approved test for the Virus.

    (shake, shake, shake, shake, shake)

    2012 will see drug trials, and maybe a new name.

    (shake, shake, shake, shake, shake, shake, shake, shake, shake, shake)
    Huh, it must be broke I just keep getting "MAYBE". (big grins)

    Oh and the following should not be construed as medical or financial advice of any kind and is intended for entertainment purposes only.
     
  3. OverTheHills

    OverTheHills

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    Hi George

    Thanks for the predictions, I think a bit of positive thinking now and again is a good thing (like my lottery-win-fantasies). OTH
     
  4. Sean

    Sean Senior Member

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    George, it ain't broke, you just need to turn up the contrast. :D
     
  5. George

    George waitin' fer rabbits

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    Ohhhh, so that's what that little bitty knob is for. Hey, if I get me some rabbit ears do you think I could get color???
     
  6. Mark

    Mark Acting CEO

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    OK...George's 8-ball sounds to me like it's still working just fine, and I wasn't expecting the BWG to 'settle all questions forever' but here's my reasoning, tell me what part of this is wrong...

    - The BWG is due to present the unblinded results of XMRV tests by the WPI and others on ME/CFS patients and healthy controls.

    - We're hoping to see the Science findings hold up under these blinded conditions, at percentages somewhere between 50%-95% ME/CFS and 2-10% healthy controls.

    - If those findings come through as expected, that will nail any questions of contamination or other procedural failures by the WPI once and for all, due to the presumed rigour of Lipkin's blinding of the samples.

    - If that is true, then it means that the WPI findings are essentially confirmed as correct, irrespective of the ability of other labs to replicate the testing procedures.

    - The BWG is also supposed to report on handling and storage procedures relevant to the detection of XMRV: no results are guaranteed, but we can reasonably hope they will have identified at least some strong possibilities as to an explanation of how and why the negative studies are failing to detect XMRV.

    - Regardless of all the other details, if the WPI's findings in Science are confirmed under blinded conditions, then the massive news story of last October is now confirmed: most ME/CFS patients are infected with a retrovirus, and 4-10% of the general population are also infected.

    - This does not prove causality. But it does pose a question that cannot possibly be avoided. I agree with the general view here that the US appears to be serious about getting to the bottom of XMRV and its relationship to ME/CFS...but I'm afraid I won't feel confident that it isn't going to all be brushed under the carpet until I see those blinded results out in public.

    - The causality question, and all the details George discussed, rightly remain open. My own view is that the circumstantial evidence suggesting that XMRV is highly likely to play a key role in ME/CFS pathogenesis is pretty overwhelming, just because it fits into the jigsaw like a hand in a glove. I'm well aware that the sceptical reaction is going to be to point out that it could be a passenger, and maybe we even pick up such passengers because of our negative attitude...of course some people are going to stick to that and go down with the ship...but for me, those kind of hypotheses clearly ought to be at the bottom of the list of probabilities, and most reasonable people will see that I think. If anybody wants to point out to me that these other possibilities exist, I'll be asking them which possibility they want to put their money on. :)

    - Continuing my chain of reasoning, though...assuming that the BWG delivers the minimum of confirming WPI under blinded conditions, and illuminating the testing controversy somewhat...then that should kick all the negative studies right into the long grass. It would be proven that the WPI are finding something that the negative studies are not, ergo the negative studies simply aren't finding it, for whatever reason.

    - If this is the case, then attention turns back to what we do know about XMRV, and back to the positive studies...and all the positive findings suddenly look like they were clearly right, and the negative findings were just missing something about how to detect XMRV.

    - And that means: 2-10% infection of the general population with a recently-discovered retrovirus that is confirmed as being linked to both ME/CFS and prostate cancer, by several studies, and now confirmed associated with ME/CFS under rigorously blinded conditions.

    I think we all know here that this last summary of the situation is fairly likely to be true; some of us are solidly convinced, others less so...but nobody I know in my day to day life would know anything about this if I hadn't told them. If I was them, I think I would feel that this is news, that ought to be communicated to me...

    I guess it's probably right that the world's media probably isn't about to dump this on their readers right now as an early Christmas present. It would only be us that would be celebrating, and since when was the quality of our Christmas of any concern to anyone? But still, with such potentially massive news, I would hope that, by Friday, we will have read lots of analysis and reports from the press about this story.

    So I guess, UT, I wasn't saying there's no point to the webinar - it will be valuable in any event and it will give more reliable and fuller detail than the press reports of Tuesday's meeting - but it's just that I'm waiting for the day when this is so much all over the media that the webinar will be repeating what we've already heard from the press. It's different on the other side of the pond, perhaps - the acronym "XMRV" is allowed to appear in print over there, apparently...(though not that the news has reached many medical professionals yet, by what I hear...).

    Once this story actually becomes the news story that it merits, the bombardment with emails from patients will seem like a fond memory of the quiet old days when the world wasn't watching. At that point, the press aren't going to be prepared to wait politely until Friday for more details: they are going to demand answers right away.

    All I was getting at was that the existence of the webinar 3 days after the news breaks seems to suggest this won't be the big splash we're waiting for...which you and George seem to agree with.

    Ending on a question: what do we know about the 2 guys - Dr. Graham Simmons and Dr. Michael Busch - who are doing the webinar? What are their specialisms? Perhaps that will give an indication of what sort of issues they will be illuminating for us?...
     
  7. LaurieM

    LaurieM

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    It says the 2 doctors are from the Blood Systems Research Institute, so I guess they are the 2 here:

    Michael P. Busch, M.D., Ph.D. http://www.bsrisf.org/i-mbusch.html

    who appears to specialise in blood borne viral transmission.

    And Graham Simmons, Ph.D. http://www.bsrisf.org/i-gsimmons.html

    who appears to specialise in viral entry & inhibitors of emerging viruses.

    I guess they wouldn't be there unless they've got something important to say - so it looks promising to me.
     
  8. George

    George waitin' fer rabbits

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    I am totally slapping myself in the head and going duh! I totally get where you are coming from now. O.K. see if this changes the course of thinking. And sorry in advanced if this bums anybody out. Now I got this second hand so it could be a wrong as a two headed cow. Now if we had some TRANSPARENCY from the BWG we could all be on the same page. (growlies)

    The LIPKIN study uses "CCC/Fukuda defined CFS patients" and a like number of "healthy controls".

    The Phase II BWG uses a set of "known XMRV Positives" and a set of "known XMRV Negatives".

    Get it? So they hand the WPI 4 positives and 9 negatives then hopefully the WPI finds 4 positives and 9 negatives.

    The only difference between this study and Phase I is that the blood samples are not "spiked" in other words they didn't take "known negative" blood and add just change the amount of virus in each tube. This time they took blood from patients "known to be positive for XMRV" and blood that was "known to be negative for XMRV" and then they test out the various assays and serology tests and load tests and see what the score cards say.

    Now the next Phase III is prevalence in the blood supply

    And then Phase IV is prevalence in the Population. But by then the Lipkin study will be done and we should know based on the use of "healthy controls" what the prevalence is, at least I hope so. (grins)
     
  9. Mark

    Mark Acting CEO

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    DOH!!!:(

    Thanks George, now I can see why I was getting all excited over nothing. Thanks for explaining why BWG Phase II is not what I thought it was. You're quite right to highlight that the reason for the confusion is the LACK OF TRANSPARENCY and INADEQUATE COMMUNICATION WITH PATIENTS - somewhere along the line I have mixed up the Lipkin study and the BWG Phase II procedures and I would have to say that's because there is less information coming out about both of the two combined than I would have expected from either one alone.

    So the pace of progress is even more glacial than I had imagined. More than one year on from the Science publication, what we are now getting excited about is the results of 13 samples from WPI patients being tested blind by the WPI and other labs. (I presume those 4 known positives must be from patients already tested by the WPI, and the 9 'negative' samples could be anybody I suppose - and no particular reason, that I can see, to assume they actually are negative).

    It's still a blind test but it doesn't rule out most of the possibilities I thought it was going to - so I can take back everything I said above: it's the Lipkin study that has the potential to achieve all that, not BWG Phase II. (And as George says, by the time Lipkin reports we should know all that anyway).

    I guess we can still also expect some kind of clues about sample preparation and storage issues etc - that was the objective of this phase, yes? To standardise testing procedures for XMRV? But it's totally up in the air as to what they may have found...or not found...

    OK: my thinking is now: BWG Phase II has the objective of standardising handling, storage and testing procedures for XMRV. If they are now ready to report that Phase II is complete that would seem to imply they should have cracked those issues. We can therefore hope for an explanation of what the positive vs negative studies controversy has all been about. But there won't be any kind of proof of that explanation until further studies have been undertaken using those protocols, and nobody will give a stuff about this meeting except us.

    I think I also now understand what the big secret meeting was, a month ago? Not concerning the BWG Phase II which we were expecting at about that time (AHA! That's where all the secrecy caused me to mix up the two!), but just the final phase of planning for Lipkin's study: a big final meeting to agree and approve exactly how his study was going to proceed, perhaps informed by the preliminary findings of BWG Phase II, and to agree that everyone involved (CAA rep included) was going to conduct the whole of Lipkin's process in secret.

    Even this might have been understandable to me, if they had merely had the decency to say: we all met, this was the purpose of the meeting, and we are keeping the details secret for the following reasons. It's the fact they didn't even do that that's got my blood boiling. They aren't even attempting to explain themselves. In case it's unclear why we have a right to better treatment than this: whose lives hinge on the outcome of their work? and where does the money come from that is paying them handsomely to solve these problems?

    And so: all the secrecy and the consequent paranoia and speculation is probably not caused by the fact that they have anything interesting worth keeping secret, but just because Lipkin has insisted on secrecy for secrecy's sake. I dunno, perhaps he wants to undermine our trust in the whole process for some reason...maybe he wants to keep our respect for science and medicine to a minimum...maybe he wants to guarantee his inability to fulfil his brief and settle the controversy...perhaps he loves fuelling conspiracy theories...or perhaps he wants us all to believe Kent Heckenlively's warnings about how he "resolved" the MMR-autism controversy...I can't see why he would want to do these things, but that's all he's achieving with this cloak-and-dagger stuff as far as I'm concerned.

    Thanks for setting me straight George - I'm a lot less confused now about what's going on...although a lot angrier...I hope we're not all going to put up with more of this sort of behaviour in 2011?...
     
  10. George

    George waitin' fer rabbits

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    Tell me about it Mark

    The whole process is just stupid, frustrating and stress inducing. I would really like to see an e-mail campaign on an avalanche scale that DEMANDS a website with comprehensive information about what is going on with who, when and why. Last night when I went to answer your post I couldn't find the place where they had outline how Phase II was set up so that I could link to it. The information get's tossed out and then disappears. It makes me crazy.

    I think the whole Lipkin Study is more about the delay processes than a real study. I don't know about Lipkin his self, some reports are that he's a monumental ass and other reports say that he's a really brilliant ass. I get the impression however that this "all the eggs in one basket" study is the ideal of Collins and Co. and that it just got hung around Lipkin's neck. I don't think the Lipkin study is even necessary really. From the dribbles and drabs of unpublished information it looks like the "answers" that would be found in the Lipkin study are pretty much known. The problems is catching everybody up to the same spot before all the funding and research moves forward. The so called Lipkin study is just a delay to give others a chance to catch up. That's just my take though.

    The BWG Phase II results are incredibly important like you say. The information should lay the "contamination talk" to bed for good and give everybody a chance to move on from the UK (and countries who are invested in Wessely)/US (and those scientist who are invested in XMRV) squabble. The BWG will be posting their results on that web site (the one that is only accessible to scientist and researchers and I would kill to know where it's located and would pay money to hack that site and start our very own wikileaks!) It will give all the information necessary in order to find XMRV the right way every time.

    Personally I'm going to be relieved to leave behind the uncertainty that the whole "contamination talk" has created not only in the patient community but in the medical community. It really will be a leap forward for us.

    (growl, growl, growl, snarl, growl, grins) Just can't stay angry for very long. Dang it!
     
  11. Mark

    Mark Acting CEO

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    Indeed George - if only anger wasn't so negative for my health I'd be a lot more consistently angry than I am: curses that I've programmed myself to pick myself up and press on no matter what gets thrown at me...

    I agree with your concept of demanding a decent online information source about these issues. The mecfsforums wiki was shaping up nicely in that regard last time I looked, by the way...but we should be demanding that information, and though it should really be the BWG themselves who put that information up, the CAA properly have a role to play there. I don't like bashing the CAA and expecting them to do everything, because in a way they're no different to the rest of us: we could all do what they're not doing. But they have the inside track on so much of what we're talking about here, and have that info in front of them anyway, so it seems just a question of priorities to present that information to the patients.

    I agree with your analysis of how the Lipkin process is effectively "playing for time". That's the overriding sense I get at the moment, that the process is being spun out and spun out to make it as slow as possible...presumably to give everyone time to reach a consensus, but who knows why really? I've felt like the info was being managed and the process deliberately slowed down ever since the Lo/Alter paper was delayed....and went from "we have detected XMRV" (in the leaked press conference) to "we have found sequences of related PMLV-Rs". That seems like the moment when the normal and slightly more open process was locked down in a way that guaranteed it would take a couple of years to resolve.

    I don't think I'm being overly impatient or paranoid about this. John Coffin, no less, originally expected a standardised test in 3-6 months. 14 months later, still we wait. So there's no question it has been slower than expected, and OK it's more complicated than expected, but it's the size of the implications that are slowing things down more I'm sure - and isn't that ironic when the size of the implications ought to dictate things need to proceed faster?!

    I get that it's important to 'get it right'. I hope that's what happens in the end. But I really can't believe that this whole "waterfall model" of science (any software developers out there get my analogy?) is fit for purpose. Science proceeds at a glacial pace for political reasons, not scientific ones, and addressing those political problems and changing the way science is conducted must surely be the most effective changes one could make to accelerate the benefits that science can bring us.
     
  12. free at last

    free at last Senior Member

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    Hi Mark and George, after reading what you are both saying, surely the score card will still be revealing as far as correct estimates of known positive and negative testing samples by the wpi wont it ? what am i missing ? Surely it will still reveal the wpi can accurately and consistently differentiate between known positive and negative samples ? And if thats so, its more than some seem to be able to do. Which seems a big deal to me. Again am i wrong to think this ?
     
  13. George

    George waitin' fer rabbits

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    Hey Free
    I expect that the score card will read pretty evenly across the board with the WPI, CDC, NIH and FDA labs all able to find the virus in the positive samples and not able to find in the negative samples. Considering that all four labs helped to develop the test they are testing I would sure as hel* hope so. (grins) The score card was pretty even last time.

    The "improved testing method" will be given out to the rest of the world via that secret dang web site. So nobody from here on out will be able to yap about contamination or not being able to find the virus. And yeah, that means McClure and Company will be standing their with their pants down around their ankles and nowhere to hide. (grins) So it's a big deal in that respect.

    The witch I think that a large part (or maybe only a few) patients have is that it took them 14 months to get here. And we are still waiting for an FDA approved test that will be paid for by insurance. We are still waiting for confirmation on if the XMRV virus family "causes" the illness and if so how. And of course we are still at least 6 months to a year from the "beginning of drug trials and that's at a minimum. So all this song and dance hasn't done anything for the patients. Heck we're still waiting for the dribbles of information that are available to reach the ears of most of our doctors.

    So yeah it's a big deal, I just want more. (big grins)
     
  14. free at last

    free at last Senior Member

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    Ok thanks for that George, and i cant agree more, The negative findings by mclure and others may in part have slowed this down further Than anyone would have liked.Hoping we can have all that behind us soon. Its frustrating George.But dont forget in the uk we have NOTHING. and are all really being carried along this wave by the US. Who in turn will likely shape any action in this country. Talk about a free meal. our goverment sucks. Your goverment departments maybe slow to progress. but ours and others around the world are not even moving. hope for something positive soon. The US is leading the world George, with out your country. I would still be ln that place of complete and utter uncertainty. In your countrys debt.
     
  15. Bob

    Bob

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    Yep, this is why I think these results will be very significant for us, if they've come to a definite conclusion for Phase II. If these results are conclusive, then there can't be any more contamination arguments, and the WPI's findings will be confirmed, so I hope that we will now be able to get on with the real research work. All the negative XMRV studies will be officially dismissed, as inadequate.

    But, because we've been disappointed so many times now, I can't help feeling that their announcement will be something like "We've completed Phase II and the results are inconclusive." But I think that they have to have conclusive results, or they can't say that they've completed Phase II. So this could be a big week for us. Maybe the most important development, so far, since October 2009.

    Sorry if I'm repeating stuff that's already been said here... This thread was too lengthy for me to read through it all today.
     
  16. Mark

    Mark Acting CEO

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    True, free at last, and after all these years, this is what has transformed the way I view the USA. That, and the people I've met through Phoenix Rising. You are a great advert for your country.

    Free at last is slightly inaccurate in one respect: in the UK we're stuck in reverse gear and accelerating away...please guys, just ignore us, and sort it out yourselves. :D

    Bob's summed it up nicely in his last post re: the speculation: seems to me that end of BWG Phase II ought to mean what it says, but nothing can be taken for granted.

    And George has summed up why this is so pathetic from a patient's perspective. Now we lose another year of our lives, while scientists work out how to do the test accurately, and more importantly work out how to persuade all the people with their fingers in their ears muttering 'rumour virus contamination don't believe you who are you?', while fending off kiddie pseudosceptics calling them every name under the sun just for doing science, and until that's all over and done with nobody can publish anything positive about XMRV, nobody is supposed to even start trying to look for any kind of insights or treatments based on the breakthrough, everyone gets slated for even suggesting trialling antiretrovirals, and we're all told it will take 10-15 years for science to plod away step by step in an old-fashioned "waterfall" model, and pointed once again in the direction of the nearest psych. Not smart enough. Not good enough.
     
  17. garcia

    garcia Aristocrat Extraordinaire

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    Freudian Slip George? ;)

    If so I think it was a good one! :D
     
  18. George

    George waitin' fer rabbits

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    huh, I'm almost 1000% sure I didn't mean too. (innocent eyes)
     
  19. pictureofhealth

    pictureofhealth XMRV - L'Agent du Jour

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    Agree Free, but don't forget Dr Bishop (& Stoye?) at the Nat.Inst.for Medical Research (Mill Hill in the UK, ? MRC funded), have just finished recruiting for their new study "XMRV and Human Disease". At least then they will be able to claim that, in spite of their original negative XMRV findings, they have now resumed their studies, (since the September Conference), in fact they've broadened them. (Although have to admit they haven't specifically mentioned that they are looking at 'XMRV and ME/CFS', though I gather from Dr Shepherd at the ME Association, that he has had a meeting/chat with both Bishop and Stoye and that they 'really want to help us').

    Something/someone must have encouraged them to take another look. Was it a shared piece of breakthrough research over a coffee with Judy, or the Lo/Alter FDA/NIH findings? I'm guessing that the NIMR is the premier UK Government research facility (though funded by industry, rather than tax payer funds - or do they end up being the same at the end of the day? Not entirely sure how this works.) and they wouldn't want to look daft or churlish if their American colleagues at FDA/NIH had definitely found something. They would want to look again. And they're doing so ...
     
  20. Otis

    Otis SeƱor Mumbler

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    First, a phase II question. Have the gotten to the point of anointing one test as "the one" or are we likely to be dealing with some degree of "confounding factors" due differences in the assays? I think each group is using their own test. With real blood involved I'm not expecting 100% consensus by any stretch.

    Secondly, in addition to buying time and apparent secrecy, the Lipkin study seems to be a "sponge" for Fiscal Year 2010 XMRV study money in CFS, which could freeze out new work. The politics could continue to lock out additional paper publications as well.

    Yes Mark, I'm familiar with the waterfall model and as integrator I'm not pleased with the notion of a 'big bang' phase at the end where all the pieces are force fit together with very little consideration for that period in advance. It makes the sorting out results that much harder, to bring this back to the subject at hand.

    Finally, I'm going to reserve judgement until the webinar us over, but I am not at all optimistic that we will get a complete and unfiltered summary. It would be a first, wouldn't. I'm counting on patient reporting from the meeting to help gauge the level of accuracy of the summary We Patient Mushrooms get.

    Otis
     

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