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Biotech / Medical : CEPH
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To: VLAD who wrote (760)5/14/1998 3:19:00 AM
From: scaram(o)uche  Read Replies (2) of 998
 
VLAD:

I've collaborated with FDA scientists and taken projects to them for conceptual discussions that led to clinical testing. I don't see it your way. The data was inconsistent, and FDA has a responsibility to require a clear demonstration of efficacy. IMO, they're trying to do their job, not punish anyone. I wish everyone would get off their case and help them to use their resources optimally. Public sentiment can't cover up the deficiencies in the Cephalon/Chiron argument.

I also hope that Myotrophin wins approval. I'd like to see the ALS patient population get the right to run the patient-by-patient experiments (combined therapy) that they want to conduct.

We need, however, a regulatory agency that doesn't let "placebo-equivalents" through to approval. FDA is walking a tough line, and we should be as understanding of their responsibilities as we are compassionate to ALS patients. There are companies out there that are trying to shove crud through the approval process.

Rick
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