gfp,
Some people on the SPPI YMB are now saying that there was no SPA in place. Technically, that is untrue. There was always an SPA in place. The FDA wanted the endpoints changed from TTP to PFS. GPCB was more than eager to agree and they did change the endpoints. This is when things get murky. It seems there was great deal of discussion/negotiation back and forth between the FDA and GPCB about the endpoints and the measurement of those endpoints. GPCB, assuming they're being honest (a big assumption at this point) genuinely felt that the FDA signed off on the endpoints (and the measurement of the endpoints) in the negoitation process. Everyone is claiming "shock" when 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, everyhting 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.) It seems that the SPA remained in place, but the AMENDMENTS to the SPA were never really formalized in a written agreement with the FDA meaning, in effect, there was no SPA.
One (female) analyst kept hammering at Raj and Lenaz--Lenaz was on the joint development committee for the drug--as to why Lenaz never asked to see the finalized SPA. Lenaz said that he had no eason to disbelieve what GPCB was telling him about the SPA. Raj pointed out that the unwillingness of GPCB to share information with SPPI was one of the reasons that SPPI started the lawsuit against GPCB. The class-action lawsuits that are sure to follow this debacle may shed some light on all of this. But I have to say that not one single analyst that I know of who followed GPCB and/or SPPI ever once asked to know exactly what was in the amended SPA. 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. Many will now argue that his actions were duplicitous, nonetheless. I'm sure the attorneys for the plaintiffs will argue that point.
Putting Neuro's churlishness aside, I'd agree that the above discussion is generally more applicable to NDA's and pivotal trials. BUT in COR's case I think a strong argument can be made that the signing off of the clinical hold and the relaxing of the limitations on the dosing needs to be clarified beyond a simple "It's ok to go ahead," or having the IND approved by the FDA just letting the 30 day notice period expire.
At first, I tended to agree with Neuro and the other posters here that you were were being rather picky about the decision from Neurology, but I did think your admonitions had some validity. Now, after watching what happended with GPCB and the FDA, I think your admonitions are even more valid. Neuro's "clean bill of health" statement does not yet seem justified to me.
Basically, the female analyst was saying to Raj and Lenaz, "Where the fuck were you guys when the investors and shareholders of SPPI needed to be protected against GPCB's incompetent (fraudulent?) behavior." American analysts on these calls, I've been told, tend to be much more lenient in their questioning of managment than their European counterparts. The tone of this female analyst's questions was alot harsher than most of the other (male) analysts. We'll see if Neuro has the balls to ask the tough questions of COR management when the time comes (like in the next CC).
So gfp, as far as I'm concerned, keep the questions and the critiques coming. Longs on these message boards tend to become too complacent, too self-deluded and sometimes too cozy with management to see things clearly. The posters here tend to rubber stamp and kiss ass after anything that Neuro says. Do they seriously think that he doesn't have a vested interest--money as well as ego--in wanting to see COR succeed? Do they seriously think that his relatively cozy relationship with COR management couldn't cloud his judgment?
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.
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