The short argument is that the trial had the partial halt because it failed and this is a long-running scam. Let’s just say that the RA would know long ago, if those were the facts, if it had failed and I doubt very much any solid RA in these relevant markets would allow those sales.
Moreover we know lots of other facts that suggest the short story is extremely unlikely. But it doesn’t stop them from constantly saying it.
As for the delay suggesting “there are any problems” with “the trial”, as someone else said, I don’t think it suggests that at all, not beyond anything that is not already publicly known and in their SEC filings. What we do know is they revised their SAP pursuant to a revised guidance document that was in draft form and should be final now but is not. It was a major change and important and I don’t think anyone ever doubted that either. During this period there was a pandemic, planetary event, entire cities and countries have been in lockdown, the US lost almost a million people… the drug regulators besides being overwhelmed, were quite busy and some things appear to have fallen behind, including policy reform, or that policy in my opinion, should be final. Even the end run of Pazdur to private publication of his segment of FDA’s apparent views, or really the personal views of the various FDA authors, suggests that people even at FDA may be frustrated with the pace, to me.
All IMHO.
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