Until we get clarification from the conf call, here's how I'm tentatively looking at the situation -
1) The clinical hold on CX-717 is partially lifted, but only for a specified/limited dose range. Presumably this means the lower doses. It might also mean shorter duration of dosing. Once the new 3 month tox data is completed and the results analyzed, then the dosing restrictions could be removed by the FDA.
2) The AD PET scan trial can resume (the only clinical trial that was still underway at the time the clinical hold was put into effect). The press release doesn't say anything about the initiation of new trials (presumably this would be OK, but subject to the dosing restrictions).
3) An ADHD Phase 2b of the type Cortex or a BP would want to run (high dosing levels, longer duration) probably can't be initiated until the new 3 month tox study is completed and the dosing restrictions are removed.
4) BP negotiations will resume but will probably not be consumated until after the FDA analyzes the new 3 month tox data and lifts the dosing restrictions.
A few other thoughts -
a) Based on yesterday's volume, we might (hopefully) be seeing some significant warrant share activity. Proceeds from those warrants would help replenish Cortex's cash, which is otherwise estimated at only $8-10 mil by year end. Warrant proceeds would reduce the need for a Q4 financing, though we might get one anyway.
b) The partial lifting of the hold (with dosing restrictions) should delay consumating the BP deal, and this delay could subsequently delay completion of the non-Ampakine in-licensing. This could be a problem if other companies are also interested in acquiring that program and have ready cash.
c) I don't remember Dr. Stoll publicly saying that they were repeating the 3 month tox study in 2 species (unless I missed it). All along we had been under the impression that the problem/deficiency was only in the short term acute studies. The FDA apparently didn't request the new 3 month tox studies, but these were probably recommended by the consultants Cortex hired, just in case. Hiring those guys was a smart move.
