A few thoughts on Cortex -
- Expectations for the Monday presentation -- a timeline update for SA trial completion/results, and the status/timeline for starting the ADHD trial.
- Wildcards for the next 6-12 months include -- a possible European and/or Asian partner for CX-1739/ADHD, and a possible deal/R+D collaboration relating to the high impacts.
SA - We know the SA trial should be wrapping up soon. As of mid-May they had 15 subjects (of 20 needed) completed the required 3 PSGs, so 5 more to go (as of May), and some of those 5 were probably already part way thru the trial. So the SA results should be forthcoming soon (Varney's estimate end of Summer), so I've been figuring ~ October. Either way it shouldn't be much longer.
ADHD - The 'biggie' is the status of the IND for the ADHD trial (when this gets the OK from FDA/Laughren there will be a collective sigh of relief). Cortex had to first do the required formulation work on CX-1739, as Varney said in March - 'We have to generate the dosage forms and undertake some stability/release studies on those and then submit that info along with other info in the IND". A factor that hasn't been discussed is the longer term tox studies that had to be done on CX-1739 in order to enable longer term dosing in humans (the ADHD trial doses drug for 4 weeks, vrs SA which was just a single dosing of drug). So the IND for the ADHD trial will have to include that longer term animal tox data. Varney hasn't mentioned having to do those longer term studies, so they were probably already done in the 2007-09 period. We know Cortex ran CX-1739 'thru the gauntlet' tox-wise long ago, to ensure that there wasn't an artifact problem like CX-717 had. So what we've been waiting for in 2010 has merely been the stability/release formulation work, which should just be routine, and which was delayed due to lack of cash resources in 2009.
Anyway, it will be good to get the timeline updates on Monday. Fwiw, I'll stick with my prediction of SA results in October, and will guess the stability/release studies for CX-1739 are completed/near completed, with IND acceptance coming ~ October also.
Also, there was no pre-R+R presentation boost in the stock price this time, unlike past presentations (not that it means much either way). I'll be more than happy if the SA results and IND acceptance come in October. Q4 should be interesting for Cortex.
