That is a great observation.
I am not sure if I am thinking too simplistic on this but we knew ahead of the results that the FDA wanted the raw data and not the curated top line report.
So, let's assume we did exactly as we said we would; we gave the FDA the raw data in a format which they require and our info on the algorithm to analyze said data. This process is all outlined in the FDA guidance documents and there is a very formal chain of command that is to followed.
But that's when the questions start to arise
Why did the FDA want the raw data in the first place? Why not the more standard top line report?
My best guess is that they desperately want these processes to go smoothly given the spotlight cast by the pandemic. Notice that I didn't say they want to find a way to approve all drugs; they just want to make sure the process appears above board. They are in the spotlight and know that we are a small company who is not well versed in this process. Just look at what happened with Relief Therapeutics. What a disaster of a release! There have been rumors that a member on their board was let go for leaking info early. The message was botched. They have been "scrambling" to reframe the narrative (all is good, that wasn't the "final" data, but interim due to Monday's updated FDA guidance) This looks bad for the company and for the FDA. It reinforces the public's opinion that the FDA has favorites it moves the goal posts for. Aviptadil probably does have benefit as described by the physician's I have seen talk about it but it doesn't even matter if people refuse to believe it has benefit (see Respert's description of the antibiotic drug).
Why not announce our analysis of the raw data before the FDA finishes theirs?
I don't even understand why we are debating this truth be told. If the FDA has the raw data and is doing their analysis on it on their own schedule (which they talk about ad nauseum in their guidance documents..."we'll do our best based on our resources" ) why would we PR the data before they are done? That seems like a horrible way to do things if the FDA wanted to see the raw data and analyze it for themselves. We committed to getting them the data so they could do their own analysis, why would we upend that process and before they've finished their work, release the results? That could once again lead to a botched release and certainly puts them in an awkward position since we control what is disclosed. If I were the FDA I would tell us to keep quiet and let them do their work so that this will go smoothly, especially so given how vocal followers of this company have been.
How are Canada and MHRA involved and what about disclosure requirements?
I am no expert in this by any stretch but if you read through the FDA website they have a whole section on what are termed "Confidentiality Commitments" They give the legalese to sharing non-public information with other regulatory agencies in other countries with disclosure only granted by the sponsor. Check out https://www.fda.gov/international-programs/in...ommitments if you are curious. You can find the MHRA one or the Canada one. Perhaps the FDA is sharing there analysis of the raw data with those countries? Seems plausible to me.
If I try to look at this objectively the only thing that stands out to me as evolving over time is the estimate for us getting the results but I am guessing it took them till the week of 2/8 to unblind. I know NP said he was "hopeful" for the week of 2/1 to 2/5 in his video but I double his estimates at this point : -) Then you need to ensure your format is as described in the CBER Guidance Documents and figure 2/15 is a gov holiday and you can see the finish line creeping forward. Anyhow, just my .02. I know others think differently but just wanted to share my rationale. I am just as optimistic as I was a month ago though perhaps a little more impatient.
Anyhow, we shall find out in 1-2 weeks! Good luck to all!
I am not sure if I am thinking too simplistic on this but we knew ahead of the results that the FDA wanted the raw data and not the curated top line report.
So, let's assume we did exactly as we said we would; we gave the FDA the raw data in a format which they require and our info on the algorithm to analyze said data. This process is all outlined in the FDA guidance documents and there is a very formal chain of command that is to followed.
But that's when the questions start to arise
Why did the FDA want the raw data in the first place? Why not the more standard top line report?
My best guess is that they desperately want these processes to go smoothly given the spotlight cast by the pandemic. Notice that I didn't say they want to find a way to approve all drugs; they just want to make sure the process appears above board. They are in the spotlight and know that we are a small company who is not well versed in this process. Just look at what happened with Relief Therapeutics. What a disaster of a release! There have been rumors that a member on their board was let go for leaking info early. The message was botched. They have been "scrambling" to reframe the narrative (all is good, that wasn't the "final" data, but interim due to Monday's updated FDA guidance) This looks bad for the company and for the FDA. It reinforces the public's opinion that the FDA has favorites it moves the goal posts for. Aviptadil probably does have benefit as described by the physician's I have seen talk about it but it doesn't even matter if people refuse to believe it has benefit (see Respert's description of the antibiotic drug).
Why not announce our analysis of the raw data before the FDA finishes theirs?
I don't even understand why we are debating this truth be told. If the FDA has the raw data and is doing their analysis on it on their own schedule (which they talk about ad nauseum in their guidance documents..."we'll do our best based on our resources" ) why would we PR the data before they are done? That seems like a horrible way to do things if the FDA wanted to see the raw data and analyze it for themselves. We committed to getting them the data so they could do their own analysis, why would we upend that process and before they've finished their work, release the results? That could once again lead to a botched release and certainly puts them in an awkward position since we control what is disclosed. If I were the FDA I would tell us to keep quiet and let them do their work so that this will go smoothly, especially so given how vocal followers of this company have been.
How are Canada and MHRA involved and what about disclosure requirements?
I am no expert in this by any stretch but if you read through the FDA website they have a whole section on what are termed "Confidentiality Commitments" They give the legalese to sharing non-public information with other regulatory agencies in other countries with disclosure only granted by the sponsor. Check out https://www.fda.gov/international-programs/in...ommitments if you are curious. You can find the MHRA one or the Canada one. Perhaps the FDA is sharing there analysis of the raw data with those countries? Seems plausible to me.
If I try to look at this objectively the only thing that stands out to me as evolving over time is the estimate for us getting the results but I am guessing it took them till the week of 2/8 to unblind. I know NP said he was "hopeful" for the week of 2/1 to 2/5 in his video but I double his estimates at this point : -) Then you need to ensure your format is as described in the CBER Guidance Documents and figure 2/15 is a gov holiday and you can see the finish line creeping forward. Anyhow, just my .02. I know others think differently but just wanted to share my rationale. I am just as optimistic as I was a month ago though perhaps a little more impatient.
Anyhow, we shall find out in 1-2 weeks! Good luck to all!
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