More PolyHeme sh.., er... "stuff":
Blood safety is not an issue with Polyheme.
You started by saying it is an issue because it relies on blood and then went on to clarify that you realize the processing theoretically can clean up the blood! So, in essence you contradicted yourself except to state that this was not what is currently being validated with the FDA.
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.
"NFLD will do real well until their current inventory is gone then they'll be stuck" -- I think not because Polyheme can just as easily be made (and is often made) by the discarded blood supply which must be discarded after 40 days I believe, so supply is not an issue. Additionally, since as you yourself recognized, the process cleans up the blood so that a contaminated blood supply would not be an issue.
See above on safety. Supply is not an issue until there is a chronic shortage (another NFLD investor wet dream). If hospitals are using all the donated blood, there will be no surplus to expire -- hence no source for NFLD.
"Last I heard, that wasn't the manufacturing process they were validating with the FDA. So you can toss that theory out the window until they run prospective safety trials using bad blood on the input side." -- Also not really correct because the trial itself will be comparing the use of Polyheme Vs Saline+Blood so any adverse events present in the blood and not in Polyheme could actually provide a safety demonstration. This is not the approval they are trying to demonstrate here but some anectodal evidence may emerge from the trial nevertheless.
Right, but not responsive. See my first response.
Let me be clear:
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.
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.
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.
4. I have never thought much of NFLD's management, but I would not short the stock ahead of the data nor would I short the stock after positive data under the assumption sales would be weak. PolyHeme will never be a billion-dollar drug, but it will be a nice seller if the safety data are positive... just not as huge as some NFLD bulls think because of the logical contradictions in their dream scenarios as noted in #2 and #3 above.
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. Specifically, I would not be surprised if even a minor (not statistically significant, but numerically larger) boost in cardiac problems shows up on the PolyHeme arm causes the FDA to issue an approvable letter asking NFLD to follow the patients for some time to verify long-term safety. I reiterate that I believe any such action would be unfair, but the FDA is neither fair nor logical, especially when in the glare of politicians and the media.
I'll let the NFLD bulls go back to calling me a moron again and leave this one alone until we see what the data and the FDA say...
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