Mike Havrilla

Updated FDA Decision Calendar: Five Decisions Before Year-End

Ulysses Benjamin Dover, I guess we will found out by the end of April if your analysis is also faulty

If you were long going into the BLA filing/acceptance you already made a lot of money - I have no position long or short in the past and no plans for a position either way in the future - only watch NFLD as part of my FDA calendar of pending new drug decisions


On Jan 05 11:14 AM Ulysses Benjamin Dover wrote:

> Mikey, once again your analysis is faulty. Like Feuerstein you miss
> the central issue of what Polyheme is. It is NOT supposed to be a
> substitute for blood when blood is available (not this version anyway,
> butt someday), it is for when somebody is bleeding out and there
> is no blood available. There is a substantial need for such a product,
> hence why the FDA walked this product through a controversial clinical
> trial and now has granted fast track. To boot, the military wants
> this product.
>
> The important data is NOT a direct comparison of how Polyheme compares
> to blood as a substitute for blood, but how close to being like blood
> for when there is a need for blood but no blood is available. In
> the prior study it was found that people who were going to die from
> bleeding out, had about a 70% survival rate with minimal adverse
> events v. getting saline. It really is simple deductive reasoning
> that if I am going to die from bleeding out because we can't get
> me a transfusion in short order and am offered a 70% chance at survival
> using Polyheme, I'm using the Polyheme.
>
> This product will receive a limited approval, the stock will rise
> and the company will be bought by a large well funded company that
> can develop and market the product further. Of course, part of that
> deal will be Dr. Gould to get a great paying job, but that's fine,
> we'll see a price north of $6 (extrapolate near term profit potential
> just on U.S. remote location trauma usage) in 2009.