You guys just don't get it. It would be great if the FDA would formalize, in writing, all the dose/duration/population permutations that would be allowed going forward, and then felt obligated to live by that written agreement. So--for one last time--There is no clinical hold in Neurology. There is no dosing restriction. That does not mean that Neurology might not limit what dose is allowed WHEN a protocol for another trial is submitted to them. It is possible that they may tell Cortex to run a longer animal tox trial (six months), since it is those animal trials which form the framework for what they'll permit in a trial protocol.
Ditto Psychiatry. They will respond to an IND which includes a trial protocol.
<<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>>
How exactly is he supposed to that? Refuse to file the IND until Psychiatry sends him a letter stating that they have received everything they want from Neurology? Hold his breath until he turns blue if Neurology does not state in writing that Cortex can dose for up to three months in a trial they havent even designed yet?
What happened to Spectrum is unfortunate and continues to illustrate the FDA's disregard for its own promises. They arent the first. I should note that this is a greater problem at the NDA stage, when the FDA faces a decision that will basically take a drug out of its control. That's not the case with an IND.
<<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>>
I'll write my Congressman about this. I'm sure he'll get right on it, making sure that the FDA provides the written guarantees that investors need to feel comfortable with their biotech holdings.
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