[EMAIL PROTECTED] (William J. Foristal) writes:
On Wed, 6 May 1998 21:08:46 EDT DocCec <[EMAIL PROTECTED]> writes:
>DocCec <[EMAIL PROTECTED]> writes:
>
>
>In a message dated 98-05-06 17:15:20 EDT, you write:
>
><< But I
> DO think they should fast track these things and even give people who
> only have six months to live the opportunity to take the drug in
>spite of
> the fact it has not passed through the NDA process. They could be
>part
> of the Phase I clinical studies. By the time these things move
>through
> the beaurocracy it's too late for the people who don't have the time
>to
> wait for the NDA approval. >>
>
>I agree, and often that's what's done. In this case, as I understand
>it, they
>still need to make enough of the drug to begin human clinical trials.
>And
>that takes time.
>Doc
Hi Doc,
That's true and it is one thing to synthesize a small amount needed for
animal studies and another to develop production even to pilot plant
levels. What did they say...a year to get to the point for Phase I
studies?
Bill
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