I've owned SRPT Aug 2012 below $10 . Have not posted on this MB but follow lots of crazies who post regularly. We will soon get some guidance as to the path to DMD treatment. I think based on the fact that the FDA hasn't made any statements and continues to take additional data is a positive clue. JMHO Maybe the kids and the investors get a positive surprise soon!
With the first interim the near term most important catalyst . Let's review the most likely outcomes and apply a risk value to each. The most likely according to the six analyst who cover the stock is the trial at 222events will not reach a 50% improvement and the trial will continue another 6 to 8 months to second interim 333 events and then be successful with a 30% improvement. My guess 20 to 30% downside risk max if this happens . There is no futility / so the trial will continue. Now if the trial is stopped at the first interim for success , the company has stated last week that outcome is possible. Then I believe + 200 to 400% is a possibility , look at ICPT. So playing the short side takes a lot of balls but not many brains. JMHO
He predicted that MNKD's FDA panel which he said his call was a 60% chance it would not recommend their inhaled Insulin and did a live blog from the panel to cover his call.Well it was recommended 13 to 1 for type 1 and 14 to 0 for type 2 diabetes. he congratulated the longs and said he was a loser on twitter.
Charles Link files amended 13g/a 2,205,626 shares with 1,345,000 issuable upon option exercise within 60 days of 12/31/2013 . 7.9% owner of about 89 million at current stock price.
Sorry Sing Sing do a little DD before you lose all your daddy's money. there is no futility measurement in the interim looks so there are only two possible outcomes one the trial will continue to the second interim or be stopped for efficacy!
Since in November Dr. Link said the trial was at 25+ MOS . I think this is the reason that the price per share has more than doubled since Jan 1 . In Jan they indicated that they expected that the 222nd death would occur in one to three months . We are now in month 2 . Dr. Link also presented the three decade + 2,000 patient post surgical Panc Cancer survival data 19 mos was consistent over the last three decades . He said they have no reason to expect that the control group in the phase 3 should vary from these #s. So if he is correct and let's use 20 mos for the control then if the trial is stopped in March the treatment group would be 39 mos and even if you raise the control to 22 mos the treatment group would be 36 mos. Of course as Irisk has tried in multiple posts to try to concoct scenarios that lengthen the MOS of the control group I have more faith in Dr. Link. So with all patients in the phase 3 at the high dose for 12 months instead of 6months it seems to me that the survival of the treatment group is exceeding any thing seen before . JMHO
No IMHO Dr. Link and Stine have little or no interest in selling out now and especially prior to a read out on the success of either or both of the platforms which could change the value of the company by multiples + 10 times. Stine is a very independent fellow! I Don't think they are concerned about the current price .
1. Long term 5 year data from phase 2 post surgical Panc c trial at ASCO with break out according to dose! 2. IDO partnership my preference would be BMY since they are the leader in IO Immunotherapy Oncology . 3. New Data from the HyperAcute Lung C trial. at ASCO. 5. Data from the IDO breast cancer trial ASCO.
AACR is a conference that is primarily geared toward early stage / preclinical data . NewLink's most advanced IDO trial which Nhyujm refers to a patients blog is a Phase 2 156 patient double blinded trial patients receiving SOC + IDO or Placebo in Metastatic Breast Cancer which began in Feb 2013 and is due for completion Jan 2015 , so your ten year call might not be correct.
Once again never let the facts get in your way. The company in their presentations has been clear that the expected survival in the control group is 19 to 21 months . Which is what has been the norm in all US studies . They also state that you can not compare to non US studies since the criteria for surgical inclusion in the socialized med countries is so much more stringent only 5% versus 20 to 25% in the US . That's why the JH study of over twenty five hundred patients over the last thirty years is important and your UK study is not relevant to this board. Once again your argument is self serving nonsense. JMHO
So you would have us believe that the resent JH study regarding survival of post surgical pancreatic cancer patients is flawed showing a consistent 19 month survival over the last three decades , you would also ask us to assume no difference in low dose high dose treatment survival results despite what was presented at ASCO , and you would have us believe that the Company's presentations are just wrong , and your analysis is correct. Sorry your arguments are self serving nonsense . JMHO
Actually the competition in IDO is INCY they have been in the clinic 6 to 9 months longer than NLNK . Although NLNK believes that they NLNK control the Patents!
This. Guess is based on what management has said publicly And a attempt to interpret what it might actually mean . They told us that they couldn't be sure that they would reach the first interim in 2013 & that's what happened. They told us that when the first interim occurs it will take , six to eight months to reach the second interim . I take that to mean eight since they tend in my opinion to be overly conservative. I also believe that January may also represent their six month conservative estimate and therefore it may be March before the two hundred & twenty second event takes place, If my guess is correct the overall trial survival will be thirty months. GLTA
Study of IDO Inhibitor in Combination with Ipilimumab for Adult Patients with Metastatic Melanoma Phase 1 / Phase 2 56 patients This is the second IPI + trial last month they started a HyperAcute Melanoma + IPI trial
Actually I would not agree with the statement that I hold the analysts opinions in high regard. But they in my opinion are fact based and should not be ignored when doing DD on an investment. As far as their calls regarding their expectation that the first interim 45%+ beat is a bar to high. They are making a couple fact based assumptions 1, in other successful Onco Immunotherapy's the MK curve widens more the further out out in time you go 2, much of the optimism has to do with a new dosing schedule that we have no experience with. So therefore they are unwilling to make some of the assumptions that are engendered by many on the board. 3, As far as the time element although it seems that we have reached a point were the likelihood of first interim success has improved they at this point don't seem willing to make that leap since we really don't know exactly how many patients have been treated for exactly how long .If we get to April with out reaching the threshold my guess is that they may have to re think their assumptions . That being said they maybe wrong primarily based on a longer survival due to all high dose for one year at a treatment schedule that we have no results to give us guidance for. And so it goes!