Let me first say I am not long or short as I am currently on the sidelines trying to make a logical decision.
My biggest concern is something I had as a scientist a few weeks ago, and something that the last SA article mentioned. Why haven't they released the data of the trial? Why would anyone want to invest in a HUGE HUGE HUGE binary decision if they are going in blind? This applies to longs and shorts.
I am not saying it will be approved and I am not saying there will be another CRL, all I am saying is what is the justification of a position here if you dont even know what you are investing in and do not have access to the data? It just seems shady to me.
So, for all those who are long and those that are short.... why exactly are you investing here without knowledge of the last 'positive' phase 3 trials? As a scientist, I invest in hype backed by data. When the data is withheld, it sends out warning signals to stay away in my opinion.
Well, personally, I understand that some of this is a black box problem, so my solution has been to buy $5.50 Jan 2015 puts to protect my position, against which I have been selling OTM calls. April will get me to a point where I have just about covered the cost of my puts so the protection will be free until Jan 2015 at the cost of limiting my April upside to $9.00 at risk of being called away (oh, with a 60% profit).
Risky to go into this unhedged simply because of unpredictability of the FDA.
Did Deerfield see the data? I would would think they did to invest that much.
Facts - Deerfield converted 1st tranche (note) to stocks. 40 million in shares
3 tranches of 40 million each, July 1, 2013, Sept 5, 2013 and Dec 9, 2013
Last tranche upon FDA approval. 40 million in shares and up to 120 million in notes, due in 2019.
This is one of the largest loans/purchases by Deerfield. Easy to look up on their website.
Follow the "Smart" Money - Read Deerfield's Mission Statement and Bio of the officer's working with MNKD. My money is on AL Mann and the giant leap forward this is going to take treatment and therapy for diabetics across the globe. We also entering a new world of inhalation treatment for a whole host of diseases.
If you're tripping over pennies and nickels, you're going to miss the dollars.
Sentiment: Strong Buy
As a scientist you should understand that it is easy for someone with limited scientific knowledge to misinterpret data and/or draw false conclusions, especially when statistics are involved. A good example of this is how some analysts are saying that A1C results from the most recent type 2 trial showed Affrezza was "worse" than RAA; however, you and I both know that the statistics show there was no significant difference between the two arms (hence equivalence), which is a clear win given the size of the data set.
Imagine how many false conclusions certain authors with degrees in political science would draw and how the science illiterate wall street traders would react. no thanks! Let the scientist at the FDA correctly interpret the data and let the approval be the main event that moves the stock.
Also, I believe Al is waiting to release additional positive data to give more leverage in pending negotiations with partners. A "but wait there's more" moment could greatly increase the competition for the deal. Similar to how he recently brought up the positive news on patent protection.
Ineverwin, the point I was making was Dr LaMattina believes that Afrezza will likely be approved based upon the clinical results, and is qualified to render such an opinion. As far as the FDA concerns regarding insulin delivered via the lungs, that contradicts the fact that the FDA already approved Exubera. In fact we now know it contradicts what the FDA thinks themselves. Plus, there are many scientific articles on the benefits of delivering insulin via the lungs.
As for the long term commercial success of Afrezza after approval, I do not believe that Dr LaMattina is the best resource to be giving an opinion. It was obvious when Pfizer developed Exubera that they ignored what the end users wanted. They thought only being inhaled would be enough. It was not. Even Sanofi understood that which is why they sold their partial rights to Exubera to Pfizer. Plus, Dr LaMattina was not on the "commercialization" side of Pfizer. He was in the R&D side.
Afrezza provides significantly more benefits then Exubera and the inhalation technology is completely different. Plus Afrezza will be convenient, and price competitive, which again Exubera was not. It seems to me that it is you that is not presenting the complete information. There are many third party independent studies that have been referenced in articles indicating the strong commercial potential of an inhaled insulin. In addition, the safety profile of Afrezza is different then Exubera. In addition, MNKD has a 8+ year ongoing study with users from previous trials continuing on Afrezza. Plus MNKD has run safety studies that Pfizer never did with Exubera.
If you are not willing to do any research on your own, then please do not ask me to do it for you. I will continue to ONLY post sourced information that I believe is relevant. No one is stopping you from posting what ever information you desire.
Let me just say that since you are a scientist you will understand the guidance to first do your research and due diligence and then you will have detailed pertinent information about the trials. If you cannot find the plentiful information released then it might best for you to look elsewhere for investment choices as this will be an indication that your specific method of scientific inquiry is better suited to areas where research is not needed.
Why ask the same question that the shorts have been posting ad naseum. Just go read the million of responses that have been made to date--- however i believe you are just another alias from the shorts on the board.