Repros Therapeutics Inc (RPRX)

[io_io]

Corpstrat - that's a good post.

Personally I don't believe Clark's (reflecting on the DewD "program survival bias" BS) mantra about "overwhelming" bad biotech trial design has much basis in reality:


1. Most Phase 2's are relatively small, and very few reach stat signif - the actual result should then be not considered reliable of effect, or even reliably that there is an effect. It just establishes a candidate and a dose, etc. And yet a Phase 2 with a signal, but without proof, MUST be tried in Phase 3 TRIALS, and with uncertainty.

2. The Phase 3 trials should then not be considered as "confirmatory" trials (maybe only the 2nd confirms the 1st), but instead are simply the real "TRIALS" - the biotechs dont know the real effect until the TRIALS are done. They are TRIALS, not formalities. Notice how in some such trials, significance is achieved very easily?

3. In the Phase 3 trials, cash, time and recruitment are all issues.

4. Also, there is clinical effect. Design the trial to make it more comfortable statistically is a waste of time in perhaps the majority of cases, as this means a smaller clinical effect, and most diseases or conditions already have a treatment, and some are possibly generics, etc. (note: this applies to Proellex, where Lupron already exists)

5. Then there is the trade-off with safety. Design a bigger trial, say in combination therapy against an approved drug, and if the clinical effect is small, you may not get approved if the safety issue over-rides.


So when you subtract all of these optimally designed trials from the mix, you don't have too many left. How many do you know if ? One per year ? Certainly when do you hear CEOs moaning about not enough power ? Hardly ever.

Personally I think that any message-board poster who makes these broad-brush statements about the industry - which is backed by talented people actually thinking and working on these drug projects - and also backed by tens or more of millions for each drug - is either naive or thinks the readers are naive.