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Microcap & Penny Stocks : Cryogenic Solutions Inc. (CYGS)
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To: celeryroot.com who wrote (3274)8/21/1998 11:57:00 AM
From: Graham Marshman   of 4028
 
Thanks,
Incidentally, I just did a quick check on some recent FDA
timelines. The FDA, as you probably know, issues a statement of total
time (in days) of both the testing and approval phases on approved
items in order to allow patent extensions. I took all the ones
reported since 8/9, eliminated one device, one food additive and one
animal product, leaving only drugs. For those five, I tabulated
total time in test phase and total time from IND to approval.
See below:

Drug Test period(days) Total period(days)
Mirapex 2024 2576
Etopophos 1029 1719
Posicon 1326 1793
Dostinex 1825 2188
Benefix 583 749

These were approved in 96/97 so still not very current, but
interesting. Average total period to approval was 4.9 years with a
max time of 7 years.

Let me just state here that this is statistically insignificant, but I
was just taking a quick sample. Looks encouraging that the FDA may be
somewhat better than the 12 year peg.
Graham
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