This is a statement directly from a doc associated with PPHM! I am not saying names because I don't want to get anyone in trouble
I'd think Tustin could connect the dots even without a name if there is a deal in the works. After all, just how many doctors in the entire country, much less your part of it, are so closely associated with Peregrine that they'd be privy to the possibility of a deal for Cotara?
That being the case, about the only way your friend won't be in trouble is if the deal is announced before tomorrow's pre-market open.
So, either you're flat-out lying or you just put someone in jeopardy for violating a non-disclosure agreement with Peregrine, which may happen regardless of the announcement.
FDA has reviewed preliminary trial data and if all goes as plan, NDA should be filed in spring early summer 2011
So, we're going to get to an NDA filing in 14-21 months before the first patient has been treated in the first U.S. trial center that has yet to be announced for a "gold standard" Bavi NSCLC trial that hasn't yet been approved by the FDA who may or may not have even received the trial design submission yet?
And, all this is based on the data from 3 non double blind, non placebo controlled cancer trials that got deprecated to "signal seeking" status? Only one of which was for lung cancer and all three run outside the U.S?
Right...
I'd like to be wrong, and my apologies to the board for "bashing" but, my money's on flat-out lie.
No matter, we should know for sure in less than 21 hours.
BTW, has anyone ever found out just what the hell a "signal seeking" trial is?
Regards,
moby