Dec 20th: High Noon for Ampligen! FDA Advisory Committee Decides Ampligens fate in live webcast
- Thread starter Cort
- Start date
jimells
Senior Member
- Messages
- 2,009
- Location
- northern Maine
A very interesting question. The media love to portray 'the markets' as some kind of monolithic being, which of course it isn't. I'm guessing that one trader's 'uncertainty' is another trader's 'sure bet'. It also seems to me that 'uncertainty' is sometimes used as a cudgel to beat up policies and people that the establishment elite don't like.
Firestormm probably has a much better answer...
urbantravels
disjecta membra
- Messages
- 1,333
- Location
- Los Angeles, CA
Los Angeles here, not Europe! But the same audio feed must be going to everyone, including the transcribers (probably a computer transcription aided by human correction, because when it's working, it's very fast and accurate.)
jimells
Senior Member
- Messages
- 2,009
- Location
- northern Maine
Cort's twitter feed reports that their web server is being overloaded by the patients! Regardless of their decision, the FDA knows we are watching them. I hope they are at least squirming a little...
snowathlete
Senior Member
- Messages
- 5,374
- Location
- UK
anyone know how the vote works?
I know that its not a final decision until Feb sometime but that that decision usually reflects todays vote. Does any majority vote count, or what?
I know that its not a final decision until Feb sometime but that that decision usually reflects todays vote. Does any majority vote count, or what?
Thanks!
Marco
Grrrrrrr!
- Messages
- 2,386
- Location
- Near Cognac, France
Quite simply in 'normal' stocks or currency trading you aim to buy low and sell high.
If stocks, currencies or any other commodity were at a constant non-fluctuating price then no-one would have the opportunity to buy low and sell high. 'Uncertainty' or the fluctuation in prices is what drives the markets - hence my (be)amusement at stockbrokers' apparent abhorrence of uncertainty.
snowathlete
Senior Member
- Messages
- 5,374
- Location
- UK
doesnt look good to me at the moment.
It looked to me that the presentation about the decision votiing criteria was presented in a very misleading way, suggesting a higher degree of certainty was needed than was really. Someone picked her up on it and was asking about whether it was reasonable doubt, or what. I couldnt make out what the answer was but its obviously not complete certainty required because no drug would ever get approved.
If i had to guess i reckon it will get rejected. The only thing in our favour is that there is clear acceptance that there is critical need for a drug to treat the illness and that patients are extremely ill with CFS/ME. I suppose it is possible that this would swing enough votes in favour of Ampligen, but who knows...
It looked to me that the presentation about the decision votiing criteria was presented in a very misleading way, suggesting a higher degree of certainty was needed than was really. Someone picked her up on it and was asking about whether it was reasonable doubt, or what. I couldnt make out what the answer was but its obviously not complete certainty required because no drug would ever get approved.
If i had to guess i reckon it will get rejected. The only thing in our favour is that there is clear acceptance that there is critical need for a drug to treat the illness and that patients are extremely ill with CFS/ME. I suppose it is possible that this would swing enough votes in favour of Ampligen, but who knows...
SpecialK82
Ohio, USA
- Messages
- 993
- Location
- Ohio, USA
Devasting vote.
A sad day for us.
A sad day for us.
Do we (patients) get any opportunity to influence that vote, like we were able to email the FDA this time around?
Like Cort is tweeting, the committee are talking about wanting further studies as though Hemispherx will go ahead and find the enormous amount of funding to do that when it hasn't been able to for the last whatever years. Sounds like they need the unrealisticness of that expectation rammed home.
snowathlete
Senior Member
- Messages
- 5,374
- Location
- UK
*sigh*
urbantravels
disjecta membra
- Messages
- 1,333
- Location
- Los Angeles, CA
Well, there ya go. I really think we have HEB's mismanagement of the clinical trials to blame for this down-vote.
I did NOT hear any of the panel members lightly brushing off the seriousness and devastation of the disease. I heard many, many comments from the panelists that they recognize the urgent need for treatments, understand patients' plight, etc. I heard what I take to be very sincere expressions of regret that despite the need, this particular set of evidence for this particular drug did not meet the required standards. Wrap up comments from Unger (?) that the FDA is "very, very, very interested" in continuing to work with sponsors to move forward on medical treatments. What other government agency has EVER expressed this level of concern and urgency about our disease?
I liked the comment by (??) (I couldn't tell who the hell was talking most of the time because of the audio drop-outs and the transcription going completely to hell in the final hours) that "rheumatologists treat bad diseases with bad drugs" (because we don't have good ones yet) and that patients are expected to be able to make their own informed choices based on the known risks of the drug. However, the majority of the panel seemed to feel that they didn't have good information about what those risks actually are.
I see an inherent problem in studying the "subgroup" that seems to respond to Ampligen because we apparently don't have any other way to define this subgroup besides "responds to Ampligen." A bit of circular logic there. As far as I know there are plenty of drugs that only x% of patients respond to, so what's the special problem here?
I did NOT hear any of the panel members lightly brushing off the seriousness and devastation of the disease. I heard many, many comments from the panelists that they recognize the urgent need for treatments, understand patients' plight, etc. I heard what I take to be very sincere expressions of regret that despite the need, this particular set of evidence for this particular drug did not meet the required standards. Wrap up comments from Unger (?) that the FDA is "very, very, very interested" in continuing to work with sponsors to move forward on medical treatments. What other government agency has EVER expressed this level of concern and urgency about our disease?
I liked the comment by (??) (I couldn't tell who the hell was talking most of the time because of the audio drop-outs and the transcription going completely to hell in the final hours) that "rheumatologists treat bad diseases with bad drugs" (because we don't have good ones yet) and that patients are expected to be able to make their own informed choices based on the known risks of the drug. However, the majority of the panel seemed to feel that they didn't have good information about what those risks actually are.
I see an inherent problem in studying the "subgroup" that seems to respond to Ampligen because we apparently don't have any other way to define this subgroup besides "responds to Ampligen." A bit of circular logic there. As far as I know there are plenty of drugs that only x% of patients respond to, so what's the special problem here?
SpecialK82
Ohio, USA
- Messages
- 993
- Location
- Ohio, USA
I blame alot of these problems on Hemispherix not the FDA. I wonder though, why did the FDA accept their application for review again this year knowing that they had not done the study that had been requested at the last denial.
I had assumed that the FDA had changed their views, it seems to be the same problems as before - am I wrong?
I had assumed that the FDA had changed their views, it seems to be the same problems as before - am I wrong?
urbantravels
disjecta membra
- Messages
- 1,333
- Location
- Los Angeles, CA
I don't think it's the job of the FDA or their advisory panels to adjust their need for more evidence to fit the sponsor's ability to pay for producing that evidence.
JustJack
put on yer dancin' shoes
- Messages
- 53
- Location
- Sacramento CA
urban, unfortunately this is the problem and has been the problem for a long time...no $$$. another study? sorry.
I remain untreated...sickening.
JJ
I remain untreated...sickening.
JJ
heapsreal
iherb 10% discount code OPA989,
- Messages
- 10,236
- Location
- australia (brisbane)
i think this shows we need more research into diagnoses, biomarkers and sub groups. then they could more easily diagnose us and put us in the right sub group to treat and have a way of monitoring how we are improving, not just patiets saying they feel better or worse??
jimells
Senior Member
- Messages
- 2,009
- Location
- northern Maine
My (very incomplete) impression is that this is an 'advisory recommendation' that is usually followed. It's hard to understand how they could say, "We know you're desparate for treatment, it's safe, but you still can't have it."
I vaguely recall a previous post mentioned the final decision will be made in February. I expect one of our members will let us know who we can send more messages to. Cort tweeted that FDA received over 700 emails prior to today's meeting. I wonder how many came from folks on this forum.
Cort , thanks for keeping us up-to-date throughout the meeting. I hope it didn't wear you out too much.
Hope123
Senior Member
- Messages
- 1,266
I had problems accessing the audio feed as well and am going to ask the FDA contact posted to hopefully get an archived video up. From the FDA site, it is unclear if they will or won't have an archive of the video:
"CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful,
archived webcasts will not be available."
This is going to go against the popular opinion perhaps but I had a lot of doubts and questions about Ampligen that weren't answered pre-meeting. However, I remained mostly neutral about this process since I thought maybe the company will have more to say now. There were things the company could have done anaylsis-wise with the data that would not be overly costly but might have helped the committee members today make better informed decisions. And I can respect the need for safety -- on the one hand, it is up to each individual person to assess how much risk vs. benefit they want to take but on the other hand, the average individual doesn't have the same experience of researchers/ clinicians in seeing patients deteriorate severely or die because of medications either. I also believe there are people out there who did not benefit or might even have had side effects from Ampligen but who are not speaking out publicly because of privacy reasons, public pressure, or concern their experiences might affect those who did or could benefit.
I'm also not convinced that a "No" vote on this drug will shut down future drug development efforts. Even with Ampligen approval, there are likely people who won't respond or have side effects with the drug who will need other drugs. And even for people who respond, Ampligen may not be the definitive treatment and we still need to look for something better.
The big question in my mind is how do we get funding from any source for clinical trials of any drug.
"CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful,
archived webcasts will not be available."
This is going to go against the popular opinion perhaps but I had a lot of doubts and questions about Ampligen that weren't answered pre-meeting. However, I remained mostly neutral about this process since I thought maybe the company will have more to say now. There were things the company could have done anaylsis-wise with the data that would not be overly costly but might have helped the committee members today make better informed decisions. And I can respect the need for safety -- on the one hand, it is up to each individual person to assess how much risk vs. benefit they want to take but on the other hand, the average individual doesn't have the same experience of researchers/ clinicians in seeing patients deteriorate severely or die because of medications either. I also believe there are people out there who did not benefit or might even have had side effects from Ampligen but who are not speaking out publicly because of privacy reasons, public pressure, or concern their experiences might affect those who did or could benefit.
I'm also not convinced that a "No" vote on this drug will shut down future drug development efforts. Even with Ampligen approval, there are likely people who won't respond or have side effects with the drug who will need other drugs. And even for people who respond, Ampligen may not be the definitive treatment and we still need to look for something better.
The big question in my mind is how do we get funding from any source for clinical trials of any drug.