Gersh, In the last conf call, Dr. Stoll said that Cortex wouldn't be commenting on the actual results of the new animal studies one way or the other until after the FDA has made its decision on lifting the hold.
Even if the histopath finding is found again in the new study, Cortex should still submit all the data to the FDA and await their input. As previously discussed, the animal data in question was the basis for the FDA allowing the Phase 2a trials to proceed in the first place, and the histopath "finding" was present in that data. Either the FDA didn't originally notice the "finding", or they did notice it but didn't deem it serious enough to red flag the Phase 2a trials. Cortex almost certainly noticed it, but apparently were unconcerned, and so proceeded with the Phase 2a trials.
So my conclusion is that the histopath "finding" must be fairly subtle, and Cortex would do some additional testing if it appears again in the new study, rather than immediately abandoning CX-717. FWIW, I'm guesstimating roughly 50/50 odds for the clinical hold to be lifted immediately vrs additional studies to be required, with the "CX-717 is toast" scenario being extremely unlikely without at least one more additional study beyond the current ones.
Today's press release is good news, since Cortex appears to be right on schedule in getting the necessary work done. Dr. Stoll isn't going to talk about whether the new data is favorable or unfavorable, but at least he's keeping everybody updated on their progress.
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