gfp,
Given what just happened with the ODAC panel meeting regarding GPCB's NDA for Satraplatin, neither Cortex nor its shareholders should assume anything about negotiations with the FDA, at least not until the results of those negotiations are FORMALIZED in writing and made available to the public.
Recents events at ODAC, it seems to me, confer an even greater responsibility on biotech analysts and newsletter writers who get to question management on CC's and in other forums.
Neuroinv needs to make sure that COR has received from both divisions within CNS the formal go ahead to dose patients (patient populations should be specified where necessary) at a certain level for a specified period of time. We should assume nothing and nothing should be left to chance by COR management. We have learned that "discussions," "negotiations," etc. with the FDA mean very little until they are formalized into a written agreement, especially on the protocols for pivotal trials. But in COR's case, Stoll needs to be absolutely sure that the "left hand" (Psychiatry) knows EXACTLY what the "right hand" (Neurology) has said and is doing and both divisions are on exactly the same page and that all these sayings and doings are formalized in written agreements that can be accessed by the public. (After the GPCB/FDA debacle, I'm not sure that investors should accept that the contents of an agreement with the FDA, like an SPA, can be kept from public scrutiny.)
Bladerunner
A very disgruntled SPPI investor
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