Replies to post #34333 on RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

Blade, Biovail has the rights to the IV/intravenous form of CX-1739 only. Cortex retained the oral form.

As for what is holding up the filing of the IND, it sounds like they've gotten input from a prospective partner to change some aspect of the original trial design (see quote below). Also, they apparently 'fixed' some aspects of the trial design.

Varney said - "There are several aspects of this clinical study which we've fixed, and we continue to have discussions around other aspects of the study, in fact we're working with potential strategic partners here to help fund the study, but also to provide us with input into the design and the cost of the study."

So Varney is apparently designing/altering the trial per the prospective partner's requirements. Varney also said - "Importantly, we basically had our own IND package ready for the submission, the only thing we have to add to the IND package is the finalized clinical design protocol."

What could the design changes be? Adding a cohort with once/day dosing, or perhaps the prospective partner wants a larger number of patients per cohort, etc. Either way, having active input from partners at this stage should be a good sign for ultimate partnering interest.

[neuroinv]

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