If I remember correctly, Dr. Recknor had to go to
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Posted On: 07/17/2023 1:47:22 PM
If I remember correctly, Dr. Recknor had to go to the trail sites and get the data from them that had already been sent to Amarex. Because Amarex was not allowing Cytodyn access to the data, they went direct to the sources. It is the same data. Amarex was to populate the correct tables to justify and support the trail results for each section of dosing, efficacy, safety etc.. Amarex did not do that so the support of the data is what the problem likely was.
We don't know what literally was the diss-connect between what was int he BLA sections and what was collected from the trial sites, but my guess is that specific patient info, the test results collected and the trial outcome was not matched up so they could not say patient a with this background showed this result from the drug. I don't know this but this would be the only way a trial's data could be good, but the BLA un useable in my mind.
I i was the FDA, I would want to know the support for trial results more than i care how good the results are. If there is any integrity dis-connect, the whole data set can't be used. The FDA wants to triangulate 3+ datapoints so each part supports the other from more than one piece of data. Just like a journalist needs to verify their sources, drugs need to verify theirs.
I am tired of reading post that claim the data is garbage or everything is good, we just need to put stuff in the right cell of the spreadsheet. Neither is correct and there must be an impossible gap to bridge.
I do wonder, because i know the protocol changed many times, if the original protocol for combo was fine and later on we tried to add to the possible level of approval as we saw the data. This would likely create a situation where what was being collected does not match with what the endpoint needed. I don't know if the receptor occupancy test (which was added later) or if it was the investigational mono trial that screwed it all up. Either way, Amarex did not run this right and Cytodyn paid them to do a job they claimed they could do.
We don't know what literally was the diss-connect between what was int he BLA sections and what was collected from the trial sites, but my guess is that specific patient info, the test results collected and the trial outcome was not matched up so they could not say patient a with this background showed this result from the drug. I don't know this but this would be the only way a trial's data could be good, but the BLA un useable in my mind.
I i was the FDA, I would want to know the support for trial results more than i care how good the results are. If there is any integrity dis-connect, the whole data set can't be used. The FDA wants to triangulate 3+ datapoints so each part supports the other from more than one piece of data. Just like a journalist needs to verify their sources, drugs need to verify theirs.
I am tired of reading post that claim the data is garbage or everything is good, we just need to put stuff in the right cell of the spreadsheet. Neither is correct and there must be an impossible gap to bridge.
I do wonder, because i know the protocol changed many times, if the original protocol for combo was fine and later on we tried to add to the possible level of approval as we saw the data. This would likely create a situation where what was being collected does not match with what the endpoint needed. I don't know if the receptor occupancy test (which was added later) or if it was the investigational mono trial that screwed it all up. Either way, Amarex did not run this right and Cytodyn paid them to do a job they claimed they could do.
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