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Biotech / Medical : CEPH
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To: IN_GOD_I_TRUST who wrote (222)5/9/1997 8:48:00 AM
From: Jonathan Rothschild   of 998
 
I listened to the meeting on the phone. FDA wants things done their way, especially when they are under attack by Congress. They came out slugging right from the start. You would think that based on prelimary discussions with FDA prior to the meeting, Cephalon officials would get an idea how FDA would approach their drug. FDA has a different agenda and it may have little to do with Cephalon. They are still without a Commissioner and unwilling to approve anything other than a hard tissue dental laser (PLSIA). Look at this week's events. Genzyme's Sepracoat, Gilead's herpes cream, generic premarin and now Myotrophin. It's as if we we're going against the other Fed. The company now has 2 choices: 1) to walk away from Myotrophin or 2) to do whatever the FDA tells them to do. One possible scenario relating to option 2 is as follows. FDA grants conditional phase IV approval. This is more than a regular phase IV approval and is fine-tuned during negotiations. The drug is made available only at academic research centers, is not listed in PDR and made available for quasi-experimental use through ALS specialists/neurologists. The ALS patient community would probably find this type of expanded access acceptable. In exchange for this conditional approval, company would be required to do a parallel controlled multi-centered study. The company is in a trap. They still want to get Midofinil approved and may face the same Advisory Committee this year. They can't afford to alienate anyone at FDA and will have to bow their heads and forget about the investment community.
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