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Pyrrhonian

03/18/14 11:33 AM

#6536 RE: flipper44 #6535

You're too nice to the non-contributors. You should at least have them wire a consulting fee to your PayPal account ;). Also section 3.2.

Mingusahum

03/18/14 11:36 AM

#6537 RE: flipper44 #6535

Thank you Flipper, this is a great evidence based response, though most of the supporting language states that the sponsor is conversing with the FDA rather than the DMC.

Therefore if Germany received interim efficacy data, than NWBO must also know. It seems much more likely that Germany was given the interim topline safety data and in gave approval based on safety+anecdotal efficacy observed in previous trials/uses.

This brings us back to the question of whether NWBO is legally required to release interim efficacy data x number of days after receiving it. If they do have the data and its good, but maybe not 100% bulletproof (given the higher bar set for PFS vs. OS), then the delay may be due NWBO conversing with FDA regarding whether FDA would accept a halt for efficacy this early in the trial.

RollitUpPlease

03/18/14 11:44 AM

#6538 RE: flipper44 #6535

Exceptional as usual Flip. I feel like we have too much good info to consider the negatives for more than 5 minutes. If anything I'm just going to hedge with a few puts to keep the chariot safe. Possible Wednesday PR? NWBO seems to like Wednesdays from my short time here.

john1045

03/18/14 1:53 PM

#6551 RE: flipper44 #6535

Great, great post!!!!