Alertmeipp, While the hold was technically "lifted", all we know for sure is that the AD PET scan trial can resume (the only trial that was still ongoing at the time of the hold), and that's about it. We investors have no idea what the upper limit is on dosing, or what the allowed dosing duration is (1 day, 1 week, 1 month, etc). For all we know, the dosing regimen used in the successful ADHD Phase 2a trial isn't allowed under the current dosing restrictions (800 mg BID for 3 weeks). If that's the case, then from a BP deal perspective, having the hold "lifted" doesn't mean much.
Beyond that, what a BP partner really needs to know is if 3 month dosing is allowed. Under the current dosing restictions, 3 month dosing in humans is probably not allowed at any dose level. So, calling the clinical hold "lifted" is not really an accurate description of the situation. It made for a nice press release headline, for about 20 seconds, until one reads that there is a dosing restriction, the extent of which is totally unknown to us investors.
The way I see it, Dr. Stoll has to give us at least some idea of the extent of the dosing restrictions. We've been largely left in the dark about the nature of the histo "finding" for over 6 months. If he does the same thing with the dosing restrictions, then uncertainty will reign and the share price will continue to erode. That might not matter so much if the company didn't need to raise money soon, but the company's own guidance is for cash levels to drop under $10 mil by year end. So investors need to know where we stand.
