You're right--the audio was essential--my thanks to the board member who sent me the audio file.
What I had not considered was the possibility of a third party having input on the ADHD trial design. When MV says the IND is essentially ready for submission, that's the hurdle I was thinking was essential--he makes clear there have been no problems observed with CX-1739.
So the delay in filing appears to reflect input from a potential 'strategic partner.' It's not Rodman & Renshaw, they don't know anything about trial design. I don't think it's Biovail, they are preoccupied with their merger and all the projects already licensed. ADHD could fit with their psych sales strategy, so it's possible--but it would surprise me.
There are a couple of ways this could be occurring:
1) A potential partner could say: We're interested, but we aren't going to commit yet--but if we did, we'd need to see a Phase IIa design that includes X Y or Z. Could be an additional clinical scale, I suppose someone might suggest an active comparator arm using Strattera or Intuniv.
2) It could be a geographic partner, EU or Japan, offering to pay a licensing fee that would offset most of the trial cost--but insisting on a change such as mentioned above.
3) More deals are being done on an option basis: A licensee pays a few million for an option they can exercise if they like the Phase IIa data, at a prespecified price.
Any of these would be net pluses for the ADHD program.
Regarding SA: So they will end up with their 20, 19 at worst. I am pleased that they are wrapping it up, and have a definite timeline for the topline data. The question remains--Has there been some anecdotal/blinded pattern of sleep apnea score change that has encouraged them to keep going this long, and to still put SA upfront and center in their corporate presentation? I hope so.
The audio information was, to my ears, much more positive than the slides taken in isolation.
NeuroInvestment
