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)
SOC estimates - This means we are approaching a critical time frame. Assuming some trial events we are at a point that if SOC estimates are in the ball park we should get the 222 very soon. If we get into May/June without the 222, the SOC estimates are off.
Last time I was in my spreadsheet I had about 10 events per month combined SOC + Trial. Will you post approximate estimated SOC events for Feb/March? Guessing 6 or 7?
What month do we mathematically hit all control patients hitting 20 MOS, assuming no trial events? That's seems like a pretty important month.
Captain, when the stock was $19 I would have agreed with you, in fact, I was planning on $6 on a vaccine fail. Things change over time. There is a new reality with IDO over the last 6 months. My guess, IDO is now worth $25 per share.
My point is, regardless of where Dr. Kennedy is going to work, he wouldn't come to NLNK if he didn't like the odds or the science.
My gut feeling are markets are whimsical. Not likely that Dr. Kennedy who worked with NLNK on the ph2 trial as a researcher is coming to Ames (it was 11 below this am) to sit through a failed vaccine trial. Dr. Kennedy could work anywhere he wanted.
There has been much focus placed on the vaccine, granted, for good reason. But if we step back and look at the IDO program this company is not a one trick pony anymore. My guess, the value of the company is roughly half vaccine outcome and half IDO. Given that the Mouth of Boston (MoB), no analyst, no biotech research firm has gotten behind the first interim success (last I knew Chimera was 20% chance of a win at the end, anybody have any updates?) of the vaccine one might surmise even more valuation to the IDO than half. Inhibitors are all the rage and accepted as fact on Wall St. for good reason. Vaccines are accepted as a show me treatment and are scoffed at, for good reason, very poor track record.
Ignore daily price movements, they are 1/2 accurate, 1/4 inaccurate and 1/2 whimsical. If you just knew where to apply the extra whimsical portion. Nobody does.
"24 month MOS in Contol group with 36 months MOS in trial group (50% benefit) 222 would have triggered in late September 2013 (just about now)" Should "September 2013" read "Feb 2014" ?
My modeling suggested that once we got past the end of Nov 2013, there was enough efficacy for a win, I couldn't say the first interim, just that things would work out. Your work may be very similar to NLNK's models and would possibly drive the conservative Dr. Link to say that he is more optimistic for a first interim win.
Lrisk, Your argument boiled down: there is not enough anecdotal or statistical evidence to prove that the vaccine works until a ph3 win. This is no different than the conclusion, after much discussion, that Robert Schwartz come to in the SA article I sited earlier. Your first comments on this board where rather naive and unassuming. Once you got a bite, your arguments became quite sophisticated. In any event, it's always a good idea to run through the possible negatives even though they have been covered already by Robert Schwartz's article and comments.
For one, that NLNK's treatment is actually hastening the deaths of the patients. Your suggesting that NLNK is harming patients with their treatment.
LRisk55's comments echo much of what was already said in Robert Schwartz's SA article, "Newlink Genetics' Pancreatic Cancer Vaccine Likely To Disappoint Investors In 2013" This was published over a year ago. From the article, "The clinical development of algenpantucel-L has followed a disjointed path that erodes confidence in regards to the product's commercial viability." Also Schwartz's has not been active on the comments section of this article to answer followup questions since July of 2013.....hmm.
jrdruggie, Most think those treatments you mention will be near a wash because there is a tendency to upstage patients with chemo from non-resectable to resectable. Those patients usually have a lower survivability. Abraxane, at best, adds 1.8 months or something. Might even boost the trial arm and we could get some CR's in this arm through chem-sensitization.