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.
teg, Not sure what you are getting at on the April 2012 protocol change.
-A histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma. To: ductal adenocarcinoma without a mention of subtypes.
There are molecular subtypes of ductal adenocarcinoma but they are all pancreatic cancer. The JH study referenced: ampulla, bile duct and duodenum but none of those are pancreatic cancer. Maybe I don't understand but the JH study made no reference to subtypes of ductal adenocarcinoma (pancreatic cancer)
I also believe what you are saying, HyperAcute PC may improve 5 year survival
rate from 10% to 30 to 35%. It is a shame Provenge does not have the chance
to show its true effects, if DNDN run a long term trial Provenge vs XTANDI,
Provenge may beat XTANDI by a big margin at 5 year survival rate too.
I have been playing this stock via options and I was fortunate enough to lock in my profits around $50 per share by buying puts (although this caused me to give back some of the profits)...I have unwound my position and made good $ but no longer have a position in the stock. Given that I made $, my ranting is a little off base but I am not sure how to re-enter or if I should. I would be more confident with some additional data from the P2 trial...that's all.
This stock is like crack to me..so even though I said I will be back in the fall, I doubt I will be able to wait that long before re-entering. Your point is valid in that I could miss the big payoff if I wait too long...
I just really expected a stop at first look and now I am having to sort out my doubts about the trial design. The change in protocol in April 2012 has me concerned.
I didn't say that node status should be or has been ignored. I gave one reason for NLNK's failure to disclose any info on it. If they know and are withholding, I would be even more inclined to think the trial will fail.
People will debate the significance of the 6-month requirement. No one can know a priori how long any patient will survive, regardless of prognosis based on stage. The median survival of most resected patients appears to be more than 6 months (which I mentioned but you ignored; you've decided that the 6 months is critical, and that's fine, though you can't/don't articulate why other than to point to other studies that don't have that requirement).
I believe it makes sense to ensure that enrolled patients be healthy enough to receive the mandated treatment (especially chemo followed by chemorads). If stage and prognosis are evenly distributed through both arms, it should be a non-issue. Yes, it's obvious that healthy, good-prognosis patients SHOULD live longer, but if algenpantucel is truly effective, the experimental arm will still eventually show a statistically-significant benefit.
So even though the trial called for an initial 45% separation first interim followed by a 30% separation second interim and a final 18% separation for success .In a successful IO you should probably see the opposite 18% followed by ,30%, and then 45%.
I was an early and large for me investor in Medarex AF was the biggest critic using very similar arguments as to why the approach would fail. What many biotech investors miss is that IO cancer treatments work opposite to the way to Chemo works . In Chemo your first remission is almost always your best and longest. With IO the results build over time and the patients in the control arm who are alive at two years will probably in a large % be dead at three years, while if successful IO in the trial group they will be alive at three years four years and beyond and thus the flattening of the KM curve.
yes and no safety issues remember if the trial group was doing worse than the control group with probably 100 or so trial group patients still getting treatment /treatment lasts one year ,they probably would have stopped additional dosing for safety concerns . so my guess is ,that indicates that trial group is doing at least as well as control and in successful IO treatments the KM curve flattens over time and the longer the trial lasts the greater separation in the curves.
I thought the sentence "study continues without modification" sums it all up. I have to feel that if there not changing anything after all this time it has to be working. I wrote AF and told him to crawl under a rock...
Thanks for giving me your opinion, we definitely agree. Just wanted to see if you were still hanging in. I'm just waiting for NLNK to settle down and then I will buy more. One thing I learned from the past is you have to give these biotech's time. I jumped ship on Imclone at 8 also... I'm not sorry for my mistakes because I learned a lot. I'm sure I'll be around for the big payday with you. I'm doing great with GLYC also, made it's move way sooner then I expected....Waiting for TRVN to pop, it's up but not a lot... Time will tell. See you at 100 with NLNK , Good Luck.
bga, I am still long, I am still bullish, I was hoping for a stop thought it was 50 50 .Sorry about your Regeneron sale maybe you should have bought it back at 10. Regarding NLNK I think that yesterdays news was what was expected by Wall Street since not one of the analysts who follow the company had called for a first interim stop a couple have said a second interim stop which is an easier comparison and the others have said they expect the trial to go full cycle . Most of the prognosticators on this MB fall into two groups those who had decided that based on their guess's the trial had be a success or the opposite that based on their guess's the first interim had to be a failure and that would prove that the trial would ultimately be a failure. In my opinion neither is correct since we don't know if there was no separation of the two groups or a 10,15,20,25,30,or 35 percent separation in the two groups in either case the trial continues and you have to decide as you did with Regeneron if you are willing to hold for the long run or sell now. Remember NewLink has two platforms HyperAcute or IDO either of which if successful could make this a large biotech . Despite the claims of the bears on this board there have been no failures so far.JMHO
I disagree about the sample size being too small. The Company has provided survival data by immune response to alpha-gal, MSLN, CEA etc.....how then can nodal status or cohort be ignored???
I also disagree on the 6 month requirement....RTOG had no survival requirement with 20 Month MOS, ESPAC-3 had 3 month survival requirement with MOS of 23 months....stands to reason that this trial's admission criteria would create a MOS of 25 months....which is exactly what the P2 trial got. I would feel much better if I saw data showing much improved survival for the 300M cohort pertaining to node positive patients. Without this data, we are all guessing while management knows...
I think there is still a chance that the drug may work as I am hopeful that the alpha-Gal is inhibiting the Galectin 3 pathway but management has not mentioned this so it may only be wishful thinking on my part.
No reason to be in the stock at this time unless management shares more data.
Teg = does that mean you sold yesterday and will revisit after 333 is suddenly announced?
AMRN is not comparing apples to apples at all to NLNK.
The six-month survival requirement is a non-issue, and meant to weed out patients with comorbidities which could influence outcomes. Depending on whose data you look at, even patients with node-positive disease are expected to have a median survival of 10 months or so (the range would be 2.5 months to 30 months, approximately). SEER and the NCDB suggest that 40-50% of patients with regional nodal disease are expected to survive one year.
I agree that it's concerning that NLNK hasn't divulged any information about outcomes and their relationship to node status, etc., in phase 2, but the numbers may be too small to make any kind of useful interpretation.
I still think that the more likely outcome of the trial is failure to meet the primary endpoint.
Yes, but it's no secret that plans can be structured around future news. Insiders can then sell into the runup to those events.
Over the last 15 months I asked you the same question, what do you think? are you still bullish? holding on or bailing? I've been a stockholder from the beginning, still am. I think it will be a great company in a few years. Would love your opinion....Remember I'm the guy that sold Regeneron at 6 dollars. wonder what happened to that stock.
Trials in cancers that are lethal within a few months on average, do not generally have delayed effects. Respectable panc or not, either way, the trial has gone on too long for a positive treatment outcome.
The only phase 3 trials to show stat sig survival data are the Abraxane/Gem combo and the FOLFIRINOX trials. Both demonstrated EARLY and CONSISTANT divergence of survival lines. I am afraid, after all this time, that the IMPRESS trial may have had a divergence of survival lines, just not robust or consistent.
Agree that RA capital was a red flag as was the 1.2 million share increase in short interest between Jan 15 and Feb 15. We were clearly the last to know. AF also knew last week....easy to be a genius when you already have the answers to the test.