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biosectinvestor

11/08/20 12:42 PM

#328034 RE: GD #328032

Agreement does not mean acceptance, when the data is presented. I doubt there is still ongoing back and forth on the SAP. But as anyone who knows anything knows, even an SPA agreement (Special Protocol Assessment) with the FDA is no guarantee, at the end of the day.

However, I expect the FDA is actually a lot more flexible at this time, based upon law and recent advances in regulation, than most shorts will ever admit.

Many companies do not modify their ClinicalTrials.org posting that frequently. And the company may be seeking additional special status so they may wish to update everything at once.

The fact that LP has not yet seen the data suggests to me they are probably still discussing something, but I doubt they would have locked the trial and set-up the unblinding without the SAP as a lock.

Karlchen

11/08/20 12:44 PM

#328036 RE: GD #328032

I know, its possible - nobody knows for sure and we can do nothing! At least we have EU and GB in the bag. Maybe we see in the Q revenue from compassionate use in the UK as Les stated. He expected 50Mill revenue, i think it was in August until the rest of 2020. No prediction, dont naile me, we will see it soon, anyway!