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FDA Neurocrine Decision Panned

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By TMFBreakerTinker
December 19, 2007

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I have seen ridiculous government actions before. Heck, 2 years ago I'm going through airline security in Minneapolis and my little 2 year old boy is taken aside, and chosen for an individual security check. IT was utterly absurd.

This FDA decision the best I can figure is the equivalent of what the Japanese use to do, and may still do, in order to protect their agriculture. If they don't like you, they just take long enough to inspect your agricultural product, like lettuce, so that it spoils in the harbor. Whoops! Sorry, our bad.

This decision by the FDA which is probably the most arbitrary and capricious decision I have ever witnessed in an government administrative agency other than in some public schools enforcing some of their ridiculous politically correct rules, or new recess guidelines, has now cost over 300 high paying, high skilled jobs in the San Diego area. Don't think that the very large and powerful biotech industry in California has not noticed this.

The FDA is being investigated on Provenge, I think this NBIX decision is so absurd that with pressure from the California delegation which is the largest in the country, and perhaps even from the governor as biotech is essential to the high tech growth in California, the FDA is going to have a lot of pressure to defend this decision as well.

According to NBIX the comparator study would take so long and be so costly that it would essentially kill the drug, yet it would produce no truly meaningful new data, and would cause NBIX to pay for further clinical testing on a competitor's drug, and then just try to keep it blinded for crying out loud.

In any event, my opinion of the absurdness of it all is not isolated. Here is something from Pin on the subject.

And I have yet to have seen any analysis, anywhere, that can adequately explain or defend this decision and this process.

Essentially, and new sleeping pill is dead in this country if this FDA decision is maintained. Any new drug being developed cannot be properly valued and assessed as the FDA is incapable of giving guidance, and incapable of keeping its word. The FDA's new mission has become the removal of any new drugs into this country, and this is only a little over the top in regard.

Something is seriously wrong here. Wrong like nothing I have ever experienced in my lifetime for a government agency, and I've seen a lot.

So the question becomes: does one buy NBIX at dirt cheap price, or just watch it perhaps do a death spiral for awhile? The company is clearly worth more than this, but if the FDA has closed the window to any new drug approvals, which this decision signals except for some very rare drug approvals, and then probably only for non-novel drugs, and then only for non-novel drugs brought by big money interests, what value is there in any biotech other than as an outsourced service company for existing big pharmas who will eventually buy these drugs on the cheap for their pipelines?

That is the big question. I don't think it can be compelling argued that something does not stink here. This decision stinks far worse than the Provenge decision. One can at least argue persuasively that the efficacy data on its own was not sufficient, if you divorce it from the surrounding facts and circumstances. On this decision it is in our face. NO NEW DRUG APPROVALS. We don't want them. Too dangerous. Even aspirin. Never know what might happen 5 years down the line, what unexpected and not yet discovered side effects they might have.

In any event, can one even buy a biotech, even one selling for this cheap now?

Tinker
P.S. This bodes horribly for a company like ACUS. I cannot see the FDA approving their product without much more substantial safety testing.