Adam Feuerstein, who has a self-proclaimed "obsession with blood substitutes", writes for TheStreet.com and is no fan of Polyheme, Northfield Laboratories hoped for blood substitute. He believes, despite Northfield's hopes and protestations to the contrary, that Polyheme will not receive FDA approval killed more than the current regimen of treatment of blood or saline and blood in tandem. While it plays out he opines:
In the meantime, Northfield will file Polyheme with the FDA and make its case for approval. There's nothing wrong with that. As an investor, however, it's better to sit on the sideline than get involved.
Say Nay To Northfield
There certainly is no doubt that before long Northfield will require FDA approval for Polyheme or a transfusion of cash . . .
In the meantime, Northfield will file Polyheme with the FDA and make its case for approval. There's nothing wrong with that. As an investor, however, it's better to sit on the sideline than get involved.
Say Nay To Northfield
There certainly is no doubt that before long Northfield will require FDA approval for Polyheme or a transfusion of cash . . .
Earlier in the week (1/9/07) Northfield announced financial results for the second quarter of fiscal 2007, which ended November 30, 2006.
Net loss of $7.6 million, or $0.28 cents per share, for the second quarter compared with a net loss of $6.3 million, or $0.23 cents per share, for the corresponding period last year.
Shareholders' equity of $56.2 million, with $51.6 million in cash and marketable securities.
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1 comment:
It is too soon to write Polyheme off. It already proved to be superior to saline in an earlier trial and the plan is to use Polyheme when blood is not available. The Phase 3 trial was only to test the safety of Polyheme in a trauma situation.
The results for those who qualified to be included in the trial were good enough to pass. If you include those who were not supposed to be included (protocol violations), it came within one death out of 700+ patients of passing. The death rate was much higher in the Polyheme patients who were "protocol violations". Why do you suppose that would happen? I believe that EMTs who were dealing with a patient who was probably going to die and who had Polyheme in their ambulance probably decided to try to save the patient's life by giving him Polyheme. That would explain why there were more protocol violations in the Polyheme patients and why there a higher percentage of "multiple protocol violations" in the Polyheme arm of the trial. An example Dr. Gould gave was a patient whose blood pressure was zero being given Polyheme.
When the data is corrected and verified (two patients had the wrong date of death in the data the Contract Research Organization gave to Northfield in the first pass), and we can compare apples to apples, I believe Polyheme will have a passable death rate (close enough to saline + blood to be explained by chance 93% of the time) and get a Not Inferior rating that is needed to get FDA approval.
The key point here is that Polyheme is not meant to replace blood, it is meant to be used in place of saline when blood is not available such as on battlefields or in rural settings. It has already passed the "superior to saline" test in a previous trial involving surgery patients who refuse blood for religous reasons. This latest trial was to prove Polyheme is safe, not to prove it is superior to saline plus blood.
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