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Biotech / Medical : Acorda Therapeutics Inc.
ACOR 0.880-13.8%Apr 10 5:00 PM EST
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To: Arthur Radley who wrote (76)10/12/2009 4:22:30 PM
From: IRWIN JAMES FRANKEL1 Recommendation  Read Replies (1) of 120
 
I read it too.

It had a persistently negative tone:

- even with an SPA FDA must review the whole;
- end point is not validated and rarely used;
- looking only at responders may not be appropriate;
- bid dosing of 10mg may produce seizure;
- walking distance and speed differential not clinically significant;
- questioned the "blinding" of the studies;

Seems to me that approval will take two things:

- Neurologists on the panel with experience using 4AP arguing that patients benefit;
- Sidney Wolfe NOT coming out against the safety.

I think there is enough experience in neurologists using 4AP that they will be supportive. That leaves Sidney Wolfe to swing it. If he buys into the safety, the AC votes to approve. If Sid claims it is an undue safety risk given low therapeutic advantage and the committee splits to even a small favorable majority then my bet is that the FDA fails to approve.

Without knowing how the AC vote goes, I am with AR that approval appears a toss-up.

All that aside, neurologists need this in their tool box. But then it is already there if they are willing to compound. So looked at another way, does the FDA want to have better control of a drug that is already in use? Or, would regularization of the manufacturing process reduce the risks of compounding errors? Or, on the other side, might an FDA approved version increase use so much that more harm is done than advantage gained?

Wish I was on the AC.

:-)

ij
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