1) I am sure it was dogs and rats, everyone's choice for the two species required. Primates are very expensive.
2) I do not believe that the dose-restriction and additional 3month tox are an impediment to a deal. There is enough data in for partners to see the profile is clean--again, if it wasn't, the hold would not have been lifted. And ot the degree to which there is uncertainty about longterm exposure to higher doses, that is true for any program at this stage, one of the reasons that deals include lower upfront payments (usually) than more mature ones...
3) I am not one to come to the defense of the FDA too often, but while the FDA does have an attitude problem and is hardly user-friendly, there are two things to keep in mind: a) the case managers and reviewers are overworked--it's not like there is someone there whose sole job is to oversee Cortex. While I don't know the number of projects each person is responsible for, I'd start the bidding at thirty. b) Because the FDA has been treated like a political play toy by Congress, it is underfunded for what it is asked to do, and demoralized, without even a permanent commissioner at this point....their 'cover your ass' mentality is partly a product of those dynamics
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