Hearing whispers of statistically significant OS advantage in 2nd line trial. Updated numbers should blow away, but company is downplaying everything now vs. pumping because they're worried about another sabotage.
Daily short volume surge points to a big downside move soon. Don't know if it means bad data or a bear raid to get shares for good data, but the indicators point to a 20% pullback.
will be presented at ASCO for 2nd line NSCLC. Amazing that an 11.7 month MOS was reported with only 54% of patients in the 3mg/kg arm had passed. To be conservative, lets assume the remaining 46% passed away the day PPHM reported its results on Feb 19. That puts the remaining 46% of patients at a minimum of 16 months since enrollment was completed in October 2011. The final MOS for the 3mg/kg arm in 2nd line NSCLC will be greater than 12 months. That is amazing. I only hope they try to drop the PPS tomorrow as I will be adding substantially.
Sentiment: Strong Buy
I have a substantial position in PPHM so I research the competitive landscape. This one popped up on the radar when Adam Feuerstein said it was one to watch at ASCO. Honestly, that doesn't usually bode well. If it gets back up around $9, I'll roll the dice selling some calls out of the money calls. Premiums are absurd.
But even a 30% haircut on a 2.6 million salary would have been more than the CMO at SNTA is making. The only variable is the value of the options. Scary.
According to the most recent Hospira SEC filing, Ramachandra was making $2.6 million with stock, cash, etc. The Chief Medical Officer at SNTA is under a million. What reason would he possibly have for leaving Hospira unless he thought the stock award at SNTA would be enought to justify the pay decrease and the commute? Then, 2 months later, he flip flops. Very strange, but if he was initially confident enough to leave a company closer to his home for roughly half of the pay something must have changed his mind. Doesn't add up.
Follow the money is usually good advice. Today, someone bet a pretty penny that the price would be between $4.50 and $10 by June's option expiration and got paid nicely for it. Sell $10 $12.50 calls and sell $5 puts, pocket the $600k in premiums when the data neither excites nor disappoints. June Op Ex PPS prediction: $6.80
Relax, pal. I didn't make the R&D chief resign prior to the most important trial results in the company's history. "Personal reasons" just doesn't cut it in my book. But good luck. I hope you make a bundle and the stock goes to $50. Maybe the trial results will be great. Maybe. But I doubt it. When thestreet says buy on the dips, you should run for the hills.
That R&D chief leaving when he did ijust reeks of something bad coming. I don't short cancer drug stocks. I think it's evil. But you remind me of myself prior to losing my #$%$ on PPHM. When they pulled out of ESMO for "personal reasons" I should have seen the writing on the wall. But I chose to look at the glass half full when I should have been running for the hills. I expect they'll be some positive survival benefits from ASCO in some biomarker subgroups but I'd expect no real survival benefit overall and I think the market will react violently if that's the case. Caveat emptor.
I tried to post a link, but it was deleted. Post 90899 on the ihub PPHM board shows ECOG status for PPHM 2nd line. My 2 points are simple. If a control arm has 75% ECOG 1 and 2 patients, it is probable to have a lower MOS than a trail with ECOG 0 and 1 patients. That's just basic science.
Also, you cite a p-value of .2 as a failure, but fail to mention the survival curve in SNTA's interim MOS data yielded a p value of .18. So, if you choose to look at one as a failure you can't ignore the other. If anything, a data set of n=80 having a similar p value to a data set of n=43 would favor the likelihood of the smaller sample size have a better chance at success.
What you fail to recognize is that the original 3mg/kg arm yielded an interim MOS of 13.1 months. The final MOS reported was 11.7 months. Thus, it is a fact that the number of censors decreased from the posting of the earlier interim results to the reporting of the updated results. You also use the control arm MOS for GALAXY-1 to state it's in line with historical averages, while in fact they are limiting enrollment to patients with ECOG 0,1 while PPHM's 2nd line trial included ECOG 2 patients, and 95% of all patients in the trial were stage IV. ASCO will be a learning experience for you on what an effective 2nd line treatment looks like. Here'a a hint...it ain't SNTA.
Just remember that even an open label single arm trial in 2nd line NSCLC that yields an MOS of 11.7 months would be good enough to advance to phase III.
I get it. PPHM success is bad for SNTA longs. The trial results will speak for themselves.
First, I wouldn't get my hopes up on 1st line data. Carboplatin has never (to my knowledge) been shown to express Phosphodyslerine so there's a question about whether or not bavi's MOA can be as effective if it's target marker is being negatively affected somehow by Carboplatin and possibly still suppressed inside the cell. In contrast, both paclitaxel and docetaxel have been shown to induce PS exposure "flipping" so you'll probably see some interesting stuff from the breast trial using only paclitaxel. Secondly, I think it's more an issue of timing. They had to submit ASCO abstracts at the beginning of the year and I'd imaging the data wasn't mature enough yet. ASCO will be interesting because we get to see if there are any complete responses or patients in remission from the 2nd line trial, as I believe there will be.
If you write it enough, it might come true. The point here is that the CEO was making the same mistakes last fall that PPHM was...citing the treatment arm had not reached MOS and the control arm had, blah blah and now he's about to pay the price when the data comes out.
I spent 3 years commuting back and forth from LA to NYC because what I was doing was going to be worth the investment in the long run. I don't care if he was commuting from Chicago to Boston, a 3 hour flight, if the company was onto something good he would have stayed. You don't think he considered the commute before interviewing, signing, and the company issuing a PR? He probably realized he was being set up as the scapegoat and bailed.
GALAXY-1 is open label, so throw your "the data hasn't been unblinded" argument out the window. And, how much worse will the damage be when a company is already running a phase III trial whose protocol is approved based on a trial that will most likely be blown up by some trial misconduct? P.S. It doesn't end well. And not my fantasy. Reality.
And as far as PPHM's control "far below historic norms", I'd contest that 5.6 months is pretty close to the 6 months that Galaxy is trying to power it's survival benefit to exceed, no? You can't win em all, Doc.
The only think smacking of delusional paranoia are those who think the R&D chief would bail prior to historic survival data being released at ASCO. More likely that something happened that botched the trial, it was found out about and he bailed; however, I wouldn't be surprised if the same entity involved in sabotaging PPHM is responsible for whatever the inevitable flaw with this trial will be when announced.
I'm not a shareholder. Never have been. I'm really only interested in PPHM, but know SNTA because they're in the 2nd line NSCLC space. For those who know the story, PPHM, too had a 2nd line NSCLC trial for their lead drug candidate in combination with docetaxel. Well, last fall someone at a CRO switched the labels on the vials between a treatment arm and placebo and blew the whole trial up. Stock dropped 84% in one day. Luckily, they've bounced back but the company verified there was "clear evidence" that someone purposefully switched the dose labeling. However, it was at about this point in their trial that they announced the error. About 3 weeks prior to a huge conference in Europe. When some of us investors found out the conference was cancelled, investor relations said it was due to personal reasons that management could not attend. Keep an eye out for any sign of the ASCO abstract being pulled and if you see it, run don't walk for the exit. Good luck.