Biotech Values

[goodJohnhunting]

Why do PPHM longs always repeat the nonsensical "Why did the FDA give approval for Bavi for phase III". I will give you credit for the "why didn't they make them redo a phase II trial to because their NSCLC trial was corrupted" nonsense as it is original.

The FDA uses it's discretion and authority to recommend/require retrial..

How dense are you PPHM longs? The FDA doesn't care if any company wants to waste their money by pushing forward into a phase III trial before solid data from a strong phase II trials shows good efficacy. The Bavi NSCLC till was a combination of Docetaxel + Bavi vs Docetaxel alone, the standard of care. There was no obvious heath issues with the combination. The FDA would not block PPHM from going into a phase III trial of docetaxel + glucose vs docetaxel alone.

That's incorrect Vinny.. It might be advisable for you to read up on the FDA's criteria.

"The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident.
For example, Retrovir (zidovudine, also known as AZT) was first studied as an anti-cancer drug in the 1960s with disappointing results. Twenty years later, researchers discovered the drug could treat AIDS, and Food and Drug Administration approved the drug, manufactured by GlaxoSmithKline, for that purpose in 1987.

Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA. The drugs that do must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug--from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured."
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm

Notice the words, "design of clinical trials"

All the best,
John