1) We have p results for phase 2, where both pfs and os are in the range that implies a more than 99 percent chance of them beeing reproduced, and not caused by randomness alone.
2) Perifosine has performed with statistical significance in about 10 different tumors
3)Ph 3 has passed t/f test by dsmb
4) Phase 3 has endured for so long, that if history is a reliable guide all but very very few placebo patients can possibly be alive around March 15, dictating that survivors in the perifosine arm has prevented the trial from having reached the 360th event.
5) correcting for end skewed recruitment, only makes a tiny dent in OS figure.
6) Drop outs due to tox are either followed up for event count, or beeing counted as an event by the time of drug termination. According to general procedures.
Tox terminants are therefore not confounders in trial extension.
In light of this I find it extremely unlikely that exam results will be nothing but outstanding, poising perifosine way above all current targeted drugs in both efficacy and non-toxicity.
Nothing can possibly go wrong, of factors that are descerible at least. If there had been issues I might have traded it, but not sit permanently in the stock.
I am here to cash in, just waiting for payday.
Wow! Is that best you can do? You and so many others are spewing baseless cheer leading BS. Absolutely pathetic. Go take a good healthy crap and maybe you'll feel better. And BTW, if Zerenex is so great why hasn't a company like AMGN purchased or partnered with KERX?
"Phase 3 has endured for so long, that if history is a reliable guide all but very very few placebo patients can possibly be alive around March 15, dictating that survivors in the perifosine arm has prevented the trial from having reached the 360th event."
Ving.. you stated the above. If this was fact wont the FDA stop the trial and conclude the drug was successful?
Ving is probably sleeping over there in Norway. Peri is fast-tracked so have your posiition ready, anything can happen at any time. The timing of everything from here on out is unpredictable. Approval is capable of coming faster than you are prepared for so don't try to time it.
Ron Bentsur, Chief Executive Officer, commented on the timing for the DSMB 180 patient look for futility. He stated, "There is a built in look for the data safety monitoring committee after half of the events occur so after 180 events occur. We are still not close to hitting the 180th event so their look will probably not occur in the second quarter but more likely in the third quarter. Remember keep in mind they are completely independent, there is no alpha spent for us with regard to that look and their look is for futility and safety. That said they are entitled to do with the data what ever they want so what I mean by that is that if they see a strong efficacy signal they are entitled to go to the FDA and discuss that with the FDA off line. We would be completely independent of that discussion given the fact that that DSMC look is completely independent of us."
Source: Q4 2010 earnings conference call 3/9/11.
Ving Congrats. Question, I have no doubt Peri will get the ok for cancer treatment in CRC, does this accelerate approval in other cancer forms for Perifosine? or do they have to go through the complete Phase I, II & III
17k shares long (lost a few $K trading CHTP) and am thinking about drawing from the surplus in my checking acct for more shares. Not because of Ving or anyone else (though you all certainly give me warm fuzzies!) but because the science just makes sense.
Still here a bit lighter though 47k shares, had to buy some actc which did not go through as planned(didn't sell the spike) oops., but counting on Aezs. Whether peri makes it or not I believe this stock is a winner. Though I enjoy all of vings posts I believe his predictions are a bit pie in the sky. There have been statistically significant successful p2 trials .005 that failed p3 due to trial size it happened to celegene a ways back. It only takes a small few to skew the results. Though I believe peri has found its niche and though the p2 crc trial was small we did find similar efficacy in the adjacent m. myeloma trial. Plus we are ahead of Merck and glaxo in bringing an atk inhibitor to market...not bad company. High levels of Patk are seen where cancers become resistant to their therapies and these high levels correlate to poor outcomes, peri inhibits this thus recreating a stable environment for the current therapy to continue its job.