sddawg, Entereg also had issues with neoplasias being found in patients at higher rates that controls. The FDA restrictions on Entereg are quite severe, but Relistor has nothing remotely close. Quite frankly, I am beginning to think you are a short coming here to sow misinformation, so I doubt you and you motives for being here.
Oh and PGNX isn't sitting on their hands. SLXP calls the shots with regard to Relistor. PGNX is just along for the ride.
ssddawg, stop with the non-sense. Entereg is NOT similar to Relistor. As far as the CRL, just what company ever releases the text of a CRL? None of them do. They should be made to do so, but they aren't required to do it so they don't do it.
Maybe he got tired of spouting the company line of glowing BS based on zero solid data.
ca_fisherman, nobody ever accused PGNX management of being good. However, this more likely falls onto SLXP as they likely control all the news flow out of Relistor, not PGNX.
It never hurts to be the first one onto the market with a drug, so PGNX/SLXP will be way better off if the ADCOM gives Relistor a thumbs up now. As far as the oral vs injectable, obviously the former is better. But for Relistor it isn't a sub-cutaneous injection not a shot as most peole think of it. As far as Relistor, the breakdown and clearance profiles will likely be more than enough to get FDA profile as long as efficacy is still good, and the data so far say the oral Relistor has good efficacy. No guarantee of FDA approval of the oral, but I would rather PGNX get exclusivity for some time frame, along with the milestones payments so PGNX can accrue some revenues. I also recall that the oral Relistor approval will generate a $50 million milestone payment from SLXP.
dcoronaus, a 0.75 hazard ratio was generated from an interim analysis of the phase II Galaxy I trial. Let's see what the final data for that trial says, but you must know that phase II trials usually aren't big enough to generate statistically significant results unless the HR is excellent. As Syenfrout stated, it won't matter to the FDA as the phase III trial is in progress and that is the key. By the way, an HR of 0.75 in the phase III trial will be good enough to generate a statistically significant result. Of course there is no guarantee the phase III trial will get that level of efficacy.
Safety doesn't appear to be an issue no matter what PROPthink thinks. Obviously efficacy is still up in the air after this early data report.
syenfrout, right on target. I meant yu give you a thumbs up but accidentally gave a thumbs down. I do think the publication is interesting, but it won't mean anything until a trial has started.
Trufflesdrive, in the webcast, they mentioned that prescreening for PSA levels would likely cut the potential market in half, but there will still be a significant market size. They will also pre-screen for patient infection status before treatment. As far as 1404, it definitely looked impressive as it beat the MRI for accuracy. We will know more about the ultimate path to approval after PGNX meeting with the FDA. I would like to see some estimates as to what the potential market is for 1404 by somebody in the know.
On target tosott123. After listening to the web cast, it seems I underestimated the potential value of 1404. As far as the anti-PMSA conjugate Abs, it was reassuring to hear that the patients who died had infections and were at risk for sepsis, and that the 2.3mg.kg dose had significantly lower grade 3/4 adverse effects. The negative was the lack of PRs and CRs but they gave some potential reasons why, and touted high percentage of patients with stable disease. I wouldn't say a home run, but definitely positive. I did try to buy more this afternoon, but just missed my limit order price. I will be looking to add more, but clearly the FDA review of the Relistor label expansion is the near term price driver.
The market has been tanking recently, and biotech is finally getting hit. As always, that is good news for people with money on the sidelines, and bad news for people who bought on margin.
syenfrout, sadly, you are correct about most posters on this board. I seldom read posts made on it anymore.
Ernie, right on target. If a stock goes up significantly before any pivotal data release, like EXEL has done, a good management team will issue some new shares to raise money as a form of insurance.