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Thursday, April 01, 2021 6:53:21 PM
Unless you’re alleging fraud, I see there to be no possible way that they have not been cleared to proceed. The FDA does not give an written all clear, generally, on an initial request to do a clinical trial including an initial SAP. Parties can request a specific thing called an SPA (a special protocol assessment) only at the beginning of a trial and they are not typical. Moreover, they are no guarantee either, on anything.
But the FDA will tell a party if they think a protocol change is inadequate or could not result in approval. They will raise issues, which a company can then answer. But there is no special “non-approval” applicable now that otherwise would not exist. Basically, they are in the same position they would be otherwise.
Lastly, this is not some surrogate measure of survival being offered to expedite the trial, for a conditional approval. They waited 14+ years in this trial to demonstrate actual survival numbers, so the entire argument is baseless. The only thing that would challenge the measure of actual survival would be if actual survival was false. I don’t see how that is possible.
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