I just finished reading IMUC2014 report transcript on SA. Here is a quote that was interesting, “Both the FDA and EMA have guided us to use overall survival as the primary endpoint as we did in phase II, because overall survival is the definitive efficacy endpoint in GBM.” Did the FDA tell NWBO the opposite? Maybe the FDA back then did, but will the future FDA still accept the past FDA’s opinion? I have seen the FDA change whims over a trial period to the chagrine of many investors and the drug co. That is why many fear FDA PDUFA dates because there can be unknown mines like manufacturing issues, unacceptable safety or efficacy data or design, etc that is not fully revealed to the investor.
The second thing IMUCmentioned was that they were encouraged by the FDA to apply for an SPA. I know that NWBO does not have an SPA for their pIII trial, but I don’t know if they chose not to apply or were rejected and didn’t tell us (anyone care to update me on this if my info is incorrect? AF is the one who brought up the issue of lack of SPA and I recall ou on this board thinking that NWBO did have an spa but I believe he is incorrect.) There is a Forbes article, “Should the FDA Force Drug Makers to discuss their Clinical trials “ that states the importance of getting an SPA to reduce the risk of the FDA rejecting the results, “ “When the FDA formally endorses a SPA, it essentially endorses the protocol thereby giving a company confidence that, if the drug performs as hoped, the FDA will readily approve it.
Surprisingly, not all companies actually seek such FDA guidance before embarking on their clinical trials. As revealed in a recent research letter to the Journal of the American Medical Association (JAMA) ), of the 35 drugs approved from February 1, 2011 to February 29, 2012, companies met with the FDA to discuss pivotal studies for 28. Furthermore, for those drugs that were discussed, the FDA made 53 recommendations to alter or modify the study protocols and only 40 were accepted.” I guess NWBO seeks to be an exception despite the added risk of not getting an SPA.
Third, IMUC mentioned something about seeking collaboration from US and EU centers to facilitate and expedite enrollment so that they could enroll 400patients in 2yrs starting 2nd half 2015. I don’t remember LP talking about such centers or if she did I wonder if that is what IMUC is referring to. They are expecting a 100sites for enrollment using those collaborations. We’ll have to see what IMUC meant by that in the near future, but competition for GBM patients is about to get even fiercer.
Also, I can concur w/ PYrr and see the near term possibility of a short term reversal. The turn occurred at 8.25 and if the close remains below that, then most likely there will be a BRIEF (hopefully) downturn like last time though I doubt we see it get down to 6.60 but long term it is still bullish. JMHO
