RespireRx Pharmaceuticals Inc (fka RSPI)

[gfp927z]

Retiredend99, Summarizing RD-1 and RD-2 -

RD-1 -

One dose level (1500 mg), tests for prevention of RD and maintenance of analgesia. 16 patients. Run by a University in Frankfurt. Used paper case report forms (slower).

RD-2 -

Three dose levels (900, 1500, 2100 mg), tests only for prevention of RD, not for maintenance of analgesia. 24 patients (8 per dose cohort). Run by a CRO in Berlin. Used electronic data capture (faster). Added 3 patients as per DSMB recommendation.


In his email, Stoll indicated that RD-2 would be the first study to be completed and analyzed, so these results should be released first. This is good IMO, since RD-2 has the higher 2100 mg dose. If there is clear efficacy at 2100 mg, we're golden. With 2100 mg in the bag, the question then is - how does efficacy look in the 1500 mg cohort? If efficacy is good there as well, then we're really golden, and we'll also know we'll be getting some useful maintenance of analgesia data from RD-1 (not necessarily positive analgesia results, but useful results). Where things get sticky - say 1500 mg shows little/no efficacy, then we're probably not going to get much use from the analgesia data in RD-1. But as long as 2100 mg showed decent efficacy, we're probably still OK, since the RD pharma partner may be able to extrapolate maintenance of analgesia from the excellent Greer rat data. The essential parameter that we absolutely have to establish is the RD prevention aspect.

The worst case scenario of course, is if there is little/no efficacy at 2100 mg. Then we're in deep trouble, and the stock to gets creamed bigtime. Getting RD-2 results first is good, since we'll get to see that 2100 mg data right away. If 2100 mg doesn't work in RD-2, it's very unlikely we'll see anything good coming out of RD-1 at 1500 mg, unless of course the CRO, with their limited experience in respiratory trials, screwed RD-2 up somehow, while the more experienced University ran a better RD-1 trial. After the DARPA experience, I guess anything can happen. Don't you just love biotech? :o)