To All Whiners:
This is not a flea market.
To gain approval for a new drug (NDA) requires enormous amounts of money and effort. It is a complicated process that is designed to rigorously evaluate a new agents potential therapeutic benefit.
Before a drug ever gets to Phase III clinical trials (in humans) it has already demonstrated safety and efficacy within given defined parameters established by the FDA.
Argatroban had a priority review status, which meant that it's perceived potential was strong (as determined by the FDA based upon preliminary analysis) and was in an area of unmet medical need.
The FDA, not the company, primarily determined how they wanted the drug tested, the basic designs of the study, the number of patients to be included to reach a p value (statistical significance), the number of sites, and so on.
Now, some companies (generally the larger ones) execute plans and conduct studies better than others: and working with the FDA is in itself a science and very mysterious and laborious. Interpretation of data is not black and white and when lives are at stake, you err on the side of caution.
A vote for non-approval means many things not one thing, and certainly does not warrant a total withdrawal of support in a product or company. IMHO.
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Lecture Section
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To insinuate we are qualified to interpret an FDA panels recommendations based upon wire reports is unmitigated audacity and dangerous (from a market standpoint).
We are here as investors! Pure and simple.
If a qualified person attends a FDA panel meeting, or if someone participated as an investigator, or is an employee of the company, then, insight into a drug is valuable. But basing investing decisions (buying or selling) on wire reports is not only untimely it is foolish!
Stick to markets you know personally and/or understand very well. There are enough of them out there to keep you busy until eternity.
Remember! Risk means Risk. Reward follows risk. But failure is the product of risk more often than not.
The science will prevail one way or the other. You have to have a belief and understanding in the science.
Happy Investing! |
