"trial is going great - we think we will succeed on the second interim, ahead of schedule". Even a wildly optimistic investor in this space would say at most 80% odds of success. Which would mean an investor who got in early or has worked 70 hours a week on the project for 18 years might want to reduce his holdings by 20% or so. Somebody with no exposure to this space might want to buy some shares even when others are selling. It is just simple probability 101 math. No conspiracy required.
In my opinion the market has placed a value of zero on the vaccine so the vaccine is all upside. Dr. Link and company have cued up so much science in the inhibitor space that it would keep BMY et al busy for the next 10 years curing cancer, which is going to happen finally. So railing on the vaccine, which will likely work in the long run with inhibitors regardless, is a mute point currently. Somebody needs to move on and start ranting about why the inhibitors are not working. Much more interesting.
AF railed on MNKD. Saying, if only Al Mann would have spent his $1 billion on some real diabetes research, etc., etc. Prior to him saying yesterday that he though there was 60% chance of failure one would have read into AFs prior comments that MNKD's treatment was a total farce. In general AF's comments are just sensational and used to whip up the twitter feed and social media. He has low credibility and slipping fast.
NVO has the most to lose because MNKD's product is fast acting. It has all the potential to be a blockbuster. There is nothing even close in the pipeline for how fast this works and how well it acts like the pancreas. For many they will still need a basal insulin. One of the patients in the trail said at the MNKD adcom yesterday....."now I can live in real time" pretty much says it all.
Is pulling all the strings to create doubt, they use words like, "missing data", "lungs", "cancer". In my opinion Novo and others are doing everything that can to create concerns. At the FDA you don't get fired for not approving something you get fired for approving something that has a problem. This is going to be an uphill battle.
Jim, It's not my line of reasoning. It is what the market is saying. Its the collective knowledge of investors voting with money. Markets can be wrong by 10x but it is very unusual.
At today's price of $29.88 per share or market cap of $835 million:
Assume the IDO program is worth $20 per share or $560 million. Then the vaccine is worth $275 million. If the full value of the vaccine approved is $1 billion then the market is saying there is a 27.5% chance of a win for the vaccine.
Because inhibitors are generally accepted and vaccines are not it is more likely that the IDO program is worth $25 per share which then puts the odds of a vaccine win at: 13.5%.
This is what the market is saying roughly. It is the summation of the collective knowledge. The other side to this is that there is now quite a bit of upside if the vaccine works.
The general consensus is that we were at 27 months blended when we hit the 222. If we look at Toad's option #2 with 24 MOS for the control and 27 MOS for the blended then we get 33 MOS for the trial group. That would roughly be 37.5% improvement. There are quite a few different estimations to get to these numbers though.
nlnk - Toad published his estimates in a post on Mar 7th at 11:52 am on this board. Not sure if it is what your looking for but it was a very good post. It had several possible scenarios.
A true scientist doesn't devote his whole life to a noble cause with the hope of cheating somebody 20 years down the road.
I know no falsehoods at all. Just different interpretations and views. My view is that many/most are ignoring the value of the IDO program. I think that the vaccine will be necessary as a complement to inhibitors. I don't think some listened to the call very well, i.e. with an open mind. I really don't think that anybody on the planet is in a better position than NLNK on the IDO platform. I think Dr. Link is driven by science and a cure, not by money or bad science. I will bet on that.
First interim stop's target is set to be: roughly be as good as the high dose group. It didn't work out. Something happened.
Second interim stop's target is set to be: as good as the blended results of ph2. What is necessary for this to work is an initial offset in the KM curves. Nobody has explained to my satisfaction how a single therapy causes an initial offset to the KM curve and a tail benefit. Will plead ignorance here as a possibility. Sure we could get a better tail offset but there is no facts to support that.
Final Look: No initial KM curve offset necessary, we only need the tail offset similar to ph2. From the CC, if the SOC goes much beyond what was estimated it gets difficult based on the powering assumptions to "prove" efficacy at the 20% benefit threshold.
lrisk or anybody else doesn't have an effect on the clinical trial or IDO efficacy. Group think is poison. I might be alone, but I enjoy lrisk's discerning views. It's always a good idea to spend time thinking about the downside, the upside always takes care of itself. Your right because your data a reasoning is right, not because somebody agrees or disagrees with your view.
In my opinion, the valuation the market places on the vaccine is minimal at this point. One point from the CC is the vaccine will be needed in conjunction with inhibitors regardless of the ph3 outcome. The main takeaway from the CC is that there is a fairly large gap between what NLNK thinks it's position is in the IDO pathway and the valuation the research community /Wall St /Big pharma (collectively the market) places on this therapy. NLNK is charging ahead at a very rapid rate with their trials/position in this space. If NLNK is right, I believe the odds are decent, there will be a IDO hookup with a big name in the next 3 months or so. If there is no hookup in roughly three months or so, then the market doesn't believe or place as high of odds on IDO as NLNK does. What I am saying is there is currently a disconnect between NLNK's thinking on IDO and the market place's thinking. If NLNK is right it won't take very long for the market place to catch up.
lrisk555, congratulations your 6 month exclusion concern was directly addressed by Dr. Link in the Q&A. Fortunately or unfortunately it was debunked. Thus, you may sleep well with your long position tonight. P.S. Keep those stock certs. under the pillow in a safe place, they are valuable.
There is a general acceptance by both the financial community and medical research community that pathway inhibitors work and are the next big thing. The same holds an opposite view of cancer vaccines.
I estimate that the market views the value of the IDO program at about $25 per share, leaving about $6 per share valuation for the vaccine. $6 per share is $150 million. I would think a vaccine that worked would be worth at least a $1 billion. Thus the market is saying the odds of a vaccine win is about 15% currently.
Those that bet early on NLNK have been backstopped with the IDO program, and if the vaccine does actually work there is a lot of upside to the stock.
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)