"Your NFLD Polyheme Views are misguided"
It seems to me that you had previously developed a wrong opinion of NFLD/Polyheme, and that misguided opinion is being compounded by your desire to prove yourself right.
"If there is a catastrophic problem with blood safety that lasts for some time -- the rabid NFLD investors' wet dream -- NFLD will not have any raw material. While NFLD claims their process can deal with known typical blood contaminants (HIV, prions, etc) there is no clinical proof. Without clinical proof of this claim the FDA will never let NFLD sell PolyHeme sourced from contaminated blood. In reality, NFLD will be able to make sales only as long as their inventory of product made from safe expired blood does not run out."
There are always unrealistic "catastrophic" scenarios we can come up with for any product that could prove our point. However, the one you describe above is not really appropriate for Polyheme. If, as you describe, all the blood in the world is suddenly faced with major contamination making it unusable, then Polyheme becomes the only alternative because, at least, they can claim to get rid of the various contaminents in the blood while no one else can. Perhaps they have not demonstrated that clinicly to your satisfaction but scientifically and logically they have because the polymerization process excludes from the blood all other components except for polymerized hemoglobin. In other words, the same process that makes Polyheme universal as a potential blood substitute is the reason why it is thought scientifically that PH is clean of the usual blood contaminents.
"1. The chance a pool of safe, expired blood to serve as a raw material for PolyHeme production will expire is small. I am not claiming otherwise as I expect there to be a surplus of safe, inexpensive donor blood available for hospital use for the forseeable future."
I agree, and thus I do not see what your argument is all about!
"2. A portion of the unbridled enthusiasm some NFLD investors have for huge revenues for PolyHeme is based upon chronic shortages of donor blood. This is an illogical position because a chronic shortage of donor blood would eliminate NFLD's source of raw material to make PolyHeme."
Wrong, the enthusiasm is not about a chronic shortage it is about unavailability of typed blood in many instances. It is about storage and shelf life; it is about universailty (no type matching); it is about the reduction in blood reactions that many patients get after regular blood transfusions; and it is about the fact that the chance of disease transmission is greatly reduced by the use of Polyheme.
"3. The remaining unbridled enthusiasm some NFLD investors have for huge revenues for PolyHeme is based upon widespread and chronic "infection" of donor blood. This is an illogical position because a chronic and widespread infection of donor blood would eliminate NFLD's source of raw material to make PolyHeme because their current trials do not answer the question of whether infected supply can be rendered safe and the FDA would require prospective trials to answer that question.'
Wrong again but this has been answered above already.
"4. I have never thought much of NFLD's management, but I would not short the stock..."
You are smart not to want to short the stock because you could easily get burnt if they demonstrate superiority, and even approval based on non-inferiority could hurt the shorts badly. As far as NFLD management is concerned, I think Dr. Gould is a great CEO and management has been very upfront, consistent and persistent throughout, so I am not sure what your problem with them is...Perhaps the only thing that bothers me is that they have not released the details of the SPA (p value requirements etc) but that seems to be the path that most biotech companies do these days...
"5. I expect the FDA, despite the SPA they signed, to have more concerns about approving this drug than most NFLD longs expect. While I think it would be very unfair, I would not be surprised given the political and media attention this trial has caused."
Just the opposite is the case here. The political and media attention regarding this "non-consent" trial has essentially placed the FDA and NFLD on the same team in order to justify that such a "non-consent" trial was worth it. Now that the trial has been fully enrolled, and thus the controversy has subsided, NFLD is in a great position Vis a vis the FDA because it is to the benefit of both to have this trial succeed and the product approved. It is not about fairness here, it is about the alignment of interests.
I think you should rethink your NFLD views and strategies...
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