Out of curiosity, does anyone know how many different regulators has the company applied to for approval. I would think that if agencies located where production facilities exist, the least that ought to happen is local inspectors check the production facilities and either approve them, or list changes needed to gain that approval.
Of course it's also possible that all are waiting for U.S. FDA action and won't take such action themselves.
While no one likes the way the FDA operates, even considers it criminal, as someone involved with biotech's for many years I know it hasn't changed that much over all the years. My first experience with this was with Genentech's first drug, TPA as I remember it, it was working miracles in heart disease, all the world knew it would be approved on initial approach to the FDA. I purchased options not due to expire until after the FDA's decision date. Instead of approving the FDA asked the company for long terms statistics on the drug, which had never been a part of the trial, the stock tanked, and I believe it took over a year to gain approval. No telling how many lives may have been lost because the drug wasn't available to patients who had heart attacks, but the FDA had their question answered showing the drug had long range benefits as well.
I have long suspected that some family or friends of FDA personnel making such decisions are profiting from such decisions. People who held very cheap puts in Genentech would have made huge profits on the FDA action, but I don't know that I've ever heard of the SEC investigating such trading.
What disturbs me the most is that all the questions I've ever heard from the FDA could have been answered positively had they approved the drug, but insisted on a Phase 4 trial in which all who received the drug provided results until the FDA decided it was no longer necessary. If it were up to me, all new drugs would go Phase 4 in this manner, then the problems in drugs like Vioxx and Fen-Fen couldn't be hidden, and bad drugs would be removed from the market, or had their labels modified. In the case of Vioxx, I believe if the side effects hadn't been hidden, the drug might be in use today, but it's use would be limited to not more than XX many days a month, or something like that.
Gary
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