What a fucking outrage. Unacceptable we say. Acorda (ACOR) announced this morning that the FDA would not accept its filing for Fampridine because of formatting issues. We reported this morning that the issues were mainly from earlier data that Elan had generated some time ago, but what really troubles is why this happened in the first place.

Here’s the rumor: Word has it that management is completely inept and that it refused to use an outside CRO to gather all the data and format the NDA for FDA submission. NDA’s are 1000’s of pages long with mounds of technical data. Companies typically use outside, professional service companies to create and format the document for electronic submission. Apparently, ACOR asked its employees to “pitch in” and help the company file itself.

The fact that the FDA refused to file the NDA makes us wonder wtf is going on with management and who is responsible for getting this thing right. Acorda is, or was, a $1B+ market cap company and for a screw up like this to occur is unacceptable. The screw up must have been blatantly obvious for the FDA to just not even bother, and notice it so soon!

If the rumor is true, that management had employees with no filing experience get the NDA ready, then something should be done. Investors are fortunate that the f-up was not something more serious and that the stock didn’t tank too bad (the stock closed down $5.09 or 20% to $19.81).

Unfortunately, the PDUFA date will now most likely be pushed back past the expected November 30, 2009 date.

Kinda makes everyone wonder “what else can we expect?”

ACOR: Blundering mistake nominee of 2009.

Image from montgomerymscenter

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