1) I do not expect any good news from the letter. It certainly would not be #2 that you suggested, because that would have been worked out with Cortex. And frankly, I don't think there are any tox studies left to be done. Cortex spent big money on the consultants and testing to try to leave no tox stone unturned. There is no test that will prove the negative. As I said earlier, this is not a question of science.
2) <<Neuro, Would these surrogate markers be sufficiently convincing to BP partners, compared to the older memory/cognition type endpoints?>> Gfp: There is no reason to do them other than to convince BP's. Since it is a surrogate, it is not as good as actual memory score changes, but it could be the first step. For example, they could receive X million upfront, with the BP paying them to run a cognition Phase IIa. If the results meet an agreed upon standard (doesnt have to be p=.05), an additional upfront payment is made that brings the total up to what it would have been if Cortex had memory data in the first place. It keeps the small company from running itself into the ground trying to establish POC, it allows the small company to run the small early trials with the drug it knows best, but it also provides the BP with some protection. This has some similarity to the model used by Targacept and GSK in their recent deal.
Here's what I wrote about the Targacept/GSK deal in NI Sept:
"Having partnered cognition with AstraZeneca, Targacept signed a major deal with GSK for most (albeit not all) of the rest of the indications likely relevant to their NNR platform. Pain is the most advanced, with TC-2596 in Phase II at present (data expected near year-end), but the deal also covers smoking cessation (ala Pfizer's Chantix), Parkinson's, obesity, and addiction. Targacept receives $35 million up front ($20 million via equity purchase), and up to "$1.5 billion" in milestones. More relevant are the payments that they can receive even for pre-proof of concept work, up to $16 million for each indication. Targacept gets to control the early stage R&D, while GSK's expertise and size will be exploited once POC is obtained in PhIIa. " The lead compound did not yet have PhII data, but the deal covered a wide range of indications. I'm not pointing to this particular scale of upfront and milestone payments (the high-impact AMPA program is less advanced, and most indications are high impact specific), but the model would be ideal for Cortex. It is collaborative, it is comprehensive. And it allows the small and the large companies to each do what they do well.
That's the kind of partnership I'd like to see, but it would be facilitated if they could show even surrogate endpoint data for CX701 pointing to relevant biological activity. And this is the kind of deal, again, with smaller upfronts and milestones due to the early stage of the high impacts, that would end the talk about settling for a buyout at a buck.
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