IDPH--Positive preliminary results for pivotal trial of ID Message Board

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Biotech / Medical : IDPH--Positive preliminary results for pivotal trial of ID

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To: WWS who wrote (37)	9/16/1996 6:30:00 PM
From: Brad C. Dunlap	of 1762

Bill, good question and I don't really know. I do know that in Idec's case it was a tough decision and they chose to hold off on filing early. Their explanation was that they did not want to take a chance of receiving a partial approval or an approval with restrictions. I believe they were fearful of the possibility of having to file twice. It's hard to imagine but a new drug application can run in excess of 100,000 pages and is extremely costly. I do know a few people who have contacted the FDA to inquire on the new cancer quidelines and came away with no information or even more confused. Idec has stated to me on more than one occasion that they're still trying to confirm the specifics. Others, believe that all the hoopla and national attention this received early this year was nothing more than a publicity stunt by Clinton and the FDA, with the reality that nothing will change. Idec believes that the decision to approve/disaprove all applications from the date of the filing within 6 months is for real and in their case they expext their filing will be complete sometime in the first half of 1997 and a possible approval sometime in the second half of the year. With the fast approvals that are starting to take place for HIV drugs [Merck's protease inhibitor approved in 40+ days] the cancer lobbyist are finally demanding an equal playing field and I believe the quick approvals for cancer drugs will happen. This ruling could be advantageous for the rest of the field. Theoretically, the early stage companies could construct their phase II studies specifically for early approval and be on the market much earlier than anticipated. This I believe will take place, but to my knowledge, has not happened yet. However, there have been approvals made within the 6 months of filing NDA. You might want to bounce this off of Immunomedics and get their insight.

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