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exwannabe

11/01/20 2:18 PM

#325078 RE: Flexroy #325065

The warrant story was much more part of the long playbook.

The short story is as always:

The hold was most likely the IA in 2015 (that LP said was expected and never denied) saw the primary PFS endpoint had issues. The details could be an actual futility finding, could be as anders suggests the FDA issuing a safety hold because the psPD looked like PD or could just be they saw psPD making a muck of it.

That the hold was lifted effected absolutely zero patients. The FDA can only issue holds if it effect patients, so by law the hold had to be released after NWBO changed the IND to end recruitment.

Even if you accept the view by anders that it was a safety call that the FDA later passed on, it was clear indication that the original primary endpoint would fail. If so, then the FDA (and EMA) will not accept that change at approval time, they will consider the change post-hoc.

That DE/UK accepted the changed endpoints in the IND only means they consider them safe for patients. Neither is tasked with determining if the change will be suitable for approval.

NWBO has been totally 100% silent on all the key issues, despite talking up other details. They are playing the social media game to get a faux story out.

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As far as warrants, they only point I would have is something like a 10% dilution to the common has happened in order to play this game. Had LP never suspended them a bunch would have expired worthless. Another large bunch would have been exercised bring in cash to avoid sales, and another large bunch would never have been issued.

So every long should see that they gave up 10% of their future award so LP could play a game that only helped specific warrant holders (or other sellers of stock over the last few weeks).

I call that disgusting. Or should I just say, typical LP.