To all those tired of the dosing discussion, skip this post :o)
Neuro, Not to be argumentative, or whip a dead horse, but..
Cortex "not appearing to expect a dosing restriction" is a lot different than there *not being* a dosing restriction.
There are several pitfalls to the "Cortex wouldn't file an IND if there was still a dosing restriction" line of thinking (in addition to the fact that we know Neurology hasn't yet completed their full analysis of the tox data) -
1) If only to avoid losing time, Cortex would still be preparing the IND in anticipation of filing it, even though Neurology hadn't yet finalized its ruling on all dosing restrictions.
2) A partial dose liberalization - this is a possibility. Let's say for arguments sake that Neurology had agreed to fully lift short term dosing restrictions, but only to partially lift long term dosing restrictions. Cortex would likely still file the IND anyway (as long as the long term dose allowed appeared to be close to the perceived general ballpark needed. But as we know, that's a wide ballpark since we have no data from the Phase 2a available to predict efficacy at lower doses (other than 200 mg which we know was a worthless dose), much less any once/day dosing data).
For me it keeps coming back to the fact that the histo/artifact phenomenon doesn't occur with short term dosing, only after long term dosing, and the phenomenon was the primary reason for the dosing restrictions and clinical hold in the first place. Therefore I won't be convinced that the histo/artifact factor is behind us until I see the FDA definitively approve *longer term* higher dosing.
That said, as an investor, we have to weigh the odds and place our bets, and I agree that the odds appear considerably better now than prior to the recent press release. I bought some stock today and will likely buy more in the weeks to come.
Hopefully we'll soon get a few more data points so we can all move on to more fun subjects like -- who will be the BP partner, how much we may get in upfronts, whether to buy that blue or red Aston Martin, etc :o)