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Re: libbyt post# 435644

Monday, 11/07/2005 8:54:45 AM

Monday, November 07, 2005 8:54:45 AM

Post# of 704047
"In Phase III clinical trials, peramivir demonstrated oral bioavailability of 2-3%, which led BioCryst management not to market the drug. However, due to the observed power of the injected formulation in mice against H5N1, BioCryst management began discussions with the US government to seek support for further development of IV and IM formulations."

There is a problem with that statement. Normally bioavailability is determined at 2 points, preclinical animal models and in humans phase 1, phase 11. A phase 111 trial runs around $50 million. To not discover a bioavailability problem until the trial fails and 50 million smackers have been spent is the height of incompetence. This excuse is also most likely not true. Their corporate partner was JNJ and they are generally not incompetent. It is also contradicted by other statements by BCRX in the same document that claim that IV peramivir gives several fold higher plasma levels than oral. If bioavailability was 2-3%, it should be more like 50 fold. There are more rats as well.

BCRX has been in trouble with the FDA for submitting false data in an NDA. Besides being unethical and medical malpractice, it is a federal crime to lie to government agencies to secure advantages. Problem with companies that lie. If they ever tell the truth, who can or will believe them? The boy who called wolf.

Above for amusement only. BCRX the stock, and BioCryst the company have separated and are 2 independent, noninteracting entities. They have as much connection as Julius Ceasar the historical person and Julius Ceasars ghost. Anyone trading the stock should just look at it as a black box of numbers existing on the internet. LOL

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