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.

Updated FDA Decision Calendar: Five Decisions Before Year-End

I agree with Adam Feuerstein's analysis of NFLD's Phase 3 trial for PolyHeme below:
www.thestreet.com/stor...

Also, the death rate for PolyHeme was 37.5% higher than the control arm in the Phase 3 trial when all 712 patients are analyzed and 18.7% higher when the 126 protocol violators are removed, which is in-line with the numbers reported in the JAMA meta analysis

712 patients: 349 got PolyHeme, 363 standard of care --> 46 patients died from PolyHeme arm (13.2% rate) vs. 35 died in control arm (9.6% rate) missed statistical gaol of non-inferiority

Excluding 126 protocol violators (18% of the patients in the study) --> leaves 586 patients to analyze resulting in 10.8% death rate for PolyHeme vs. 9.1% in control arm, which results in achieving the non-inferiority goal for statistical analysis for PolyHeme

Among the 126 pateients excluded for protocol violations --> 23% death rate for PolyHeme (17/70) vs. 12.5% for control arm (7/56)

NFLD got a nice pop on acceptance + priority review yesterday so you were right to be long. However, the FDA typically prefers intent to treat analysis which better reflects real world conditions, especially in the case of emergency medical treatment such as the PolyHeme trial so I don't think they will accept the exclusion of 126 protocol violators to achieve non-inferiority.

I have not traded or invested in NFLD long or short, but it looks like most people are taking their profits today with the stock down about 20% at this point. Finally, I hope that a safe blood substitute can be developed at some point to address the needs you outlined, but I don't think PolyHeme is the answer.