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Re: None

Tuesday, 07/21/2020 2:11:58 PM

Tuesday, July 21, 2020 2:11:58 PM

Post# of 44784
It seems to me that PSTI is lowering expectations on completing trials on Covid-19 to the point where data on CLI could lead to approval. Should that occur, just the data on Covid-19 could lead to its use without a formal approval as off label use.

Of course just getting approvable data doesn't mean approval comes instantaneously, but perhaps it could if the regulators made the determination that this is the course to take to make the drug available.

Perhaps I'm wrong, perhaps the company will reveal what's happened with many more of the patients who received the drug under compassionate use terms, but if not, the guidance is saying it will be awhile before we see data from any of the formal trials.

Gary