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Biotech / Medical : Lidak Pharm. [LDAKA]
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To: Henry Volquardsen who wrote (588)9/10/1997 3:52:00 PM
From: James Silverman   of 1115
 
Henry,
First, thanks for the tip on Cornerstone, I'll take a look.

In regards to projecting the timing of an FDA approval:
The quickest review on record was for MRK's crixivan-at something like 45 days. Obviously there is no comparison between the importance of introducing a life saving PI than a herpes drug. Crix was on the extremely fast track and was truly a special situation. A 6 month review would also be very fast and more akin to a life saving drug such as a cancer therapy or perhaps additional protease inhibs that come along. I believe IDPH's drug for certain types of cancer will be approved after about 8 months, having been preapproved after about 6.
HMR's Allegra-the replacement to Seldane took 10 months to be reviewed/approved. This drug also was important since it replace Seldane, which was known to have fatal drug interactions for some users.
I would say a conservative view and one that I expect LDAk will take is that the review should be expected to take one year although it is out of there hands as to the specific timing. Expecting anything faster than this may be aggressive based on the track record of the FDA in approving non-critical and non-life saving drugs.
Now I am sure we can all agree that Lidakol is not a life saving and critically important drug that should be fast tracked?
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