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neuroinv

07/26/07 2:40 PM

#7690 RE: bladerunner1717 #7683

Gfp: I expect that some mention will be made regarding the closure of the open file with Neurology--either as part of an IND PR (if they are close in time) or on its own. It's barely material--unless the FDA throws a curve, which can happen, though I consider it unlikely.

"Clean bill of health": I have several times stated that it is my opinion that the FDA, in this current hyperconservative regulatory climate, would not have permitted resumption of higher dosing of CX717 if it continued to have concerns regarding safety. It's my conclusion from reading the tea leaves, which in fact is what companies dealing with the FDA have to do all the time. I have no problem with the concept that others may formulate different opinions. But Those who want the clarity and certainty of adherence to formalized written agreements are not likely to find it in the drug/biotech sector. That's why the risk/reward dynamic is so huge, on both sides.

Blade: <<No Neuro, I'm not asking you to write your Congressman. I'm just asking to you treat Stoll like something other than your bed partner.>>

Just because you had yet another stock turn against you does not justify your taking it out on me. I don't make the rules (or the FDA's refusal to play by them). If there are questions you want asked of Cortex on a CC, you call in and ask them. If you don't, don't blame anyone else, it will be your own cojones that will be in question.

NeuroInvestment
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horselover45

07/26/07 2:58 PM

#7691 RE: bladerunner1717 #7683

Complacent??

I doubt that anybody is complacent.Some of us when we have questions we go to the source.I am sure that either R. Stoll or Jim Coleman will be glad to talk to you and tell you what they can or able to.
I am not as knowledgeable as many of you and I have called and gotten insight on my thoughts.Maybe you can do the same.

Andy C.
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DewDiligence

07/26/07 3:14 PM

#7693 RE: bladerunner1717 #7683

[OT SPPI] >…Pazdur opened up the ODAC panel meeting by saying that those endpoints were still under review. (Fine time to let the sponsor know!!! Whatever happened to the "Critical Path Initiative?"!!!!) In any case, everything went to hell in a handbasket after that. The vote was 12-0 to wait for the OS numbers to come in. (Those numbers should be available in about six months.)<

Sooner. That’s according to PHRM, and they ought to know because the final OS data are required by the EMEA as a formal update to PHRM’s pending MAA.

>All one of the analysts had to ask was "Did the FDA formally sign off on the amended protocols in the SPA?" No one asked. Maybe they just assumed. If Seizinger, CEO of GPCB, had said "yes," then he would have been lying.<

Seizinger has answered in the affirmative on various occasions. So the real question is what the definition of formally is :-)