That was why Manish Singh was fired and not even given termination fee. The original plan was to enroll 200 patients at the minimum. Manish kept giving out PRs saying that 200, 270 patients were enrolled whereas they were just being screened. With time running out, they managed to enroll only 124 patients. With 200 patients, there was a good chance that they would have hit stat sig and approval based on P2. Now it is almost impossible with low patient enrollment. It can still happen but odds are low. That is why Yu keeps stressing that they are prepared for phase 3 and are in the process of registering phase 3 trial.
They seem to hype a little bit - just oposite to IMUC. Stock will jump initially and then fall. Good short at the open if you have the resources and some guts. The drug may prove to be wonderful eventually but a trial size of 25 and showing about 4 months improvement at this stage is nothing to brag about and bragging is what they are doing. HR of 74 is good but again the trial size is very small. The other trial with n=70 has only 43 HR at this stage. Again good for hype but nothing to write home about yet.
They have, in fact, added more patients to the trial. Per clinicaltrials.gov, the estimated population size was 200. But they finally enrolled 278. There were several rumors as to why they did that. One rumor wa that Dr.SIngh screwed up and they had to add more patients.
Nevertheless the trial size is 278. Dendreon's IMPACT (phase 3) had 275 patients and the results led to Provenge's approval.
The trial had 12 patients. Comparing that phase 2 to ICt-107 phase 2 is a no-no. FDA was not even impressed with the criteria for testing the drug - 6-minute walk. Compare that to the crteria for ICT-107; you know.. patient being dead or alive. I cannot believ that the CEO of SRPT was upset with FDA because they told him that phase 2 was inadequate.
The ultimate contra indicator was Adam F being bullish on SRPT. He must have helped push the stock to $50+. He is ultra bearish on IMUC and even mocks ICT107 trial. If you are looking for a contra indicator, this is it.
No. I have not known him holding 260K shares. That is why I asked you how you know that he owns 1M shares. Is is some proprietary information that you can share the source with everybody?
Where do you get the information that Yu owns 1M shares? Accordng to Yahoo insider transactions, he owns just 10K shares. Does he have options for 1M shares ? Once an officer leaves the company, his/her transactions are not reported. So we dont know if Singh has any shares at all.
Even if Yu has 1M shares, the fact that he sold 260K shares is not very comforting.
He is THE guy. According to form-4, he acquired the shares at 25 cents a share and transferred to a family trust. He then sold all of them - 265K+ - at $2.90 a share. It happened on 10/18 and 10/21 and form-4 was filed on 10/22. So it should have been there on nasdaq website prior to CC. Mitch Gold of Dendreon (destroyer of Dendreon) used to do this all the time. He sold at $2 and $50 and anything in between as soon as shares were available for him to sell. Should have followed his lead. I would have made a lot of money.
I guess this is how CEOs play the game. They keep getting new options and they sell the shares as soon as they are vested. Dilution, shylution! Do they care? No. Peons like retail longs take risk with their hard-earned money looking for the pot of gold at the end of rainbow.
Isnt it oversimplifying? May be patients in control arm are living longer. Perhaps CRO already knows that 64 events happened and are in the process of unblinding and tabulationg results. That is why it is very critical to know if IMUC would be notified whenever 64 events happened. Yu and Gengos were not forthright in their answers to that question. If it takes 3 to 4 months to get the top line results after 64 events, in theory this could have happened in the second week of July.
Then the question is if 64 events happened in July 13, what are the odds of achieving stat sig? What date is most likely to "guarantee" stat sig? Is it third week of September or first week of December?
You are one of the most knowledgeable posters. Could you please throw some light on these questions and comments? TIA
I wonder about this theory that longer it takes for 64 events, better for ICT107. With due apologies to patients in the control arm, if 64 events did not occur in a certain time period, doent it mean the standard care is so good that these patients are living longer than the median of 18 months? So there is an optimum time that 64 events have to occur for the trial to succeed (again my apologies to the brave and unselfish patients in control arm).
Even at 64, it will be touch and go.That is why Yu is being very cautious as well as he kicked out Manish who had a tendency to exaggerate results. Provenge had an advantage of 4.3 months in median OS benefit. Extandi (MDV3100) apparently had 2.2 months advantage when the study was stopped. Mind you this study had 1700 patients. Jury is still out regarding the separation of curves etc., Zytiga was a complete fraud. J&J used their muscle to get it approved in pre-chemo area although the curves separated only after 24 months. It could have been fluke.
So when Dr. Yu says things like the approved therapy has shown only 2.5 month advantage etc., he is not necessarily predicting 3-month benefit from ICT-107. He is perhaps bringing people down to earth by letting them realize GBM is a horrible disease and any new therapy with any improvement in terms of median OS and quality of life is a clear positive. This is not a baseball game where it is all about numbers. If someone thinks that not achieving 9-month OS advanatge is a failure are being flippant and not seeing the big picture.
when they say they do not have any inkling to phase 2 results. When questioned if they would be notfied by CRO regarding 64-events and database lock, Yu started with a no but ended somewhat ambiguously.
If you follow Adam F on Twitter, he seems so happy to predict that the trial will fail, data will be mined and a phase 3 will start based on the mined data. Dont know why he is so happy with the supposed failure of a trial.
It seems they are worried about full disclosure and other legal mumbo jumbo. Perhaps underpromise and over deliver? Dr. Singh was a bit hyping type. I think thats why he was booted out. Clash of personalities. Gengos is in sync with Yu; hence such a downbeat CC - unnecessarily. These guys may downplay the results even if they are stellar. As long as 64 events did not happen yet, everyday adds confidence to the success.
I dont believe they are in "data compiling" stage yet. That means 64 events did not happen so far. Does anyone think they are in "data compiling" stage right now?
I wonder if the numbers are already known and they are in the "data compiling" stage. Did they talk about partnership before? Is it possible that top-line results are okay to proceed to phase-3 but not enough to file a NDA? AH bid/ask is 2.50/2.58. Doesnt mean much. But no guarantee of spectacular results and hence stock languishes in the current range... ?
Look what happened to EAT. Just like I predicted. They missed on revenue, EPS and then cut forecast for the fiscal year. Doesnt matter. Stock went below $40 for a brief time and then zoomed right back to where it was before earnings. All in just 2 trading days. I wont be surprised if it goes to $50 by yearend at this rate. This is pure gambling. You have to be on the right side (player/banker).
One would think stock will go down. But I am not so sure. They could sen it to $45. All restaurant stocks are overvalued - way overvalued. Patronage is decreasing. Food quality is usually horrendous. No growth prospects at all. But stock prices do not go down. Even if they do, they climb back quickly. I suppose it is due to QE.
What Brinker did was buy back millions of shares to show "doble-digit" growth in EPS. If you take out the share buyback, the earning are almost flat as is revenue. Still, I think they will push up the stock. Where to put so much easy money printed by Fed?
Double? CLDX has market cap of $2.64 bil. If IMUC doubles, it will have a market cap of 280 mil. That is about 1/10 of CLDX. Why such dispaity?
Just like CLDX. I think the overhang is that P-2 may not be enough for any approval - conditional or otherwsie. Then they will need to sell some stock to fund future phase 3 trials. Of course, nothing happens in biotech as per conventional wisdom. The results may be so good that FDA may approve conditionally. That kind of event and people on the sidelines will miss a huge rise in stock price. That could even result in a quick buyout.
On the other hand, phase 2 may be a bummer. The odds of such outcome are very low. But one cannot rule out anything in biotech.
Is CLDX going to eat IMUC lunch? I have a fair number of shares of IMUC and nothing in CLDX. But the way CLDX keeps climbing almost everyday makes me wonder. Are its P-3 results a foregone conclusion? Are CLDX and IMUC targeting the same patient population? TIA