What's a CRL?The word is that HEB received a 70 page CRL from the FDA late Friday afternoon. HEB is preparing their response/PR which will probably be released this afternoon.
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What's a CRL?The word is that HEB received a 70 page CRL from the FDA late Friday afternoon. HEB is preparing their response/PR which will probably be released this afternoon.
What's a CRL?
Oh - found it on google - it's 'Complete Response Letter' and is issued by the FDA when they're not approving a drug and tells them what changes need to be made before it can be approved.What's a CRL?
I'm more than a bit baffled that Hemispherx would leave Bob Miller still on his hunger strike if they've known the FDA's decision since Friday.
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Hi Laurel - I asked that! See post #22 above.Thanks, Johnny. What's a CRL?
The response is complicated - Hemispherx must comply with a host of SEC regulations. They said they will respond as soon as they are able to.
SEC? US Securities and Exchange Commission?
I think that you're being overly optimistic. Dr. Unger is committed to initiating a dialogue that will result in a broad umbrella definition with severity scales:Speculation on my part. Regarding identifying sub-groups and those severely afflicted. I think this is what the CDC has been doing with their multi-site clinical assessment. They started this assessment in July, posted to webiste in November, results are due this month or next I believe.
In November 2011, she described three phases in creating the new definition, i.e., data collection, the selection of severity scales and dialogue:Dr. Unger: It’s a broad umbrella with various degrees of severity. There are lots of approaches that we could take. I do not think that any one approach is absolutely wrong, but we have got to start the dialog, we have got to make it data‐driven, and we have to be unified.
However in October 2012, Dr. Belay predicted that the data wouldn't be evaluated until the fall of this year:Dr. Unger: As far as change, we are going to start with our clinical contract and getting advice from our clinical colleagues who are directly involved.... We are going to start with data collection.... That is step number one.
Step number two is, if we have good measures of the domains...then we try to say how can we capture this the best way.... We have to use a dynamic range in all of those measures. It is not enough to have just fatigue, but how much fatigue? It is not enough to have any one measure.
Going by what has happened at CDC in the past, we will next convene a meeting of experts.... We can anticipate that it will be at least one year before we could start the dialog in the process.
Dr. Belay: We are asking [the contractors] to use their best clinical judgment from their years and years of experience to select CFS patients and then collect as much data as possible from all those cases and provide it to us independently so that we will be able to evaluate the different case definitions and see where they stack up.
Mr. Krafchick: What’s your timing on that?
Dr. Belay: We’ve already completed the enrollment in 30 percent of the cases. I would say the study will be completed within a year.
It isn't clear from Dr. Belay's comments in October what phase of the study is expected to be completed within a year.Dr. Rose: When will those data be ready?
Dr. Belay: They have started collecting the data, but I can’t give you a date because it’s dependent on those physicians, not us at CDC. Some of the sites have already started enrolling patients and we’re shooting for about 400 patients eventually to be enrolled. If that happens within the next 16 to 18 months, that will be great.
I notice that Cort recently commented, “The study was just greatly expanded; its now a five year study with biological samples included….”Regarding identifying sub-groups and those severely afflicted. I think this is what the CDC has been doing with their multi-site clinical assessment. They started this assessment in July, posted to webiste in November, results are due this month or next I believe.
Hemispherx BioPharma (NYSE MKT:HEB) has said it plans to request a meeting with the FDA regarding the regulatory agency's decision to to reject approval for its Ampligen drug for chronic fatigue syndrome (CFS)....
Hemispherx said in its statement on Monday that it plans to request an end-of-review conference with the FDA to discuss the agency's decision....