News Focus
News Focus
icon url

rstor1

02/26/08 10:09 AM

#3455 RE: corpstrat #3454

If an overseas trial expedites access to Europe, the value of RPRX is that much higher.

Is there a reason that you believe:

1. A trial conducted ex-US with FDA approved protocols will have more weight with the EMEA than one conducted in the US. (And we don't even know where ex-US is - may well be Asia)

2. There has been any kind of discussion with the Europeans about trials

3. Lacking any evidence of 1 and 2, it is worth the risk of a poorly run trial to curry favor on spec.

Bob
icon url

iwfal

02/26/08 11:33 AM

#3461 RE: corpstrat #3454

The "beef" is probability of success. Unless that probability is very low, RPRX is a screaming buy. And unless worries are couched in these risk-return terms, the commentator is either insincere or financially innumerate. So c'mon guys, with your little niggles about 85% powered and two times this, bring it down to brass tacks. Are you saying there's a 90% chance the PIIIs will fail? 80%? 70%? Or 5%? Because we are being paid to accept less than certainty of success, to put it mildly!

Corp - not exactly fair to RockRat (or myself). People have learned through hard experience in biotech to doubt everything - is the trial being run on the cheap in eastern europe? did the management team change the entrance criteria between the Uf ph iib and the anemia trial? is there a self selection issue with the anemia patients reported? ... . I believe that if you brought back a block buster drug from 2040 and gave it to 30 different small biotechs only one would be successful at getting it onto the market. Most small biotechs make multiple gaffes - but they aren't all of one flavor so lots of questions need to be asked.

Is Repros mgt better than most biotech? Unquestionably. But precise calibration is good. Are they in the top 5 of that thirty - or are they the one?

Note that as someone who has only loosely followed the company for a while and only very recently tracked closely I haven't yet boiled down the 4 or 5 key questions in my head - and in the process of my doing so you will see lots of chaffe (to mix metaphors). Hopefully that isn't too annoying.

Clark
icon url

exwannabe

02/26/08 5:58 PM

#3478 RE: corpstrat #3454

Prob of succcess in anemia

This is all off the cuff, just to sugest discussions.

1) Efficiency. Let's guess that 90% is the true power. That yeilde .9*9 = .81

2) Safety. This seams fairly clear. I will give it a .9

3) CMC. I only care about major issues because a minor issue can be shown to a partner and still generate cash. .95

4) The FDA doesn't accept the trial design as sufficient for approval. No SPA, small trial, some ex US. .8

5) The ex US arm is screwed up. .9

6) Other. In the words of Cheney the "unknown unknowns". .9

That yeilds .499

Fair Harbour Statement: All the above was pulled directly out of my A*** :-)