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To: Steve D. who wrote (4727)1/16/2000 5:30:00 PM
From: KAKALAK  Read Replies (1) | Respond to of 4891
 
FROM THE RB BOARD:

By: shaggydogs
Reply To: 2385 by MisterFurter
Sunday, 16 Jan 2000 at 12:42 PM EST
Post # of 2388

MisterFurter, I think that your impression that ADVR doesn't have data to submit to
the FDA for approval may be wrong. There is the Dominican Republic, Barbados, and
Argentina data, where two of these sets can be considered clinical in nature, along with
other data like that referred to by Dr. Hirschman in his November presentation,
concerning PWAs from New York and Paris whose conditions were vastly improved
by mixing Substance R with the HAART cocktail.

EOM

Regarding the PWA's from the US and France:
We all know that FDA INDA'a are to be submitted in short order.
Was there any significance to the French PWA being French or for that matter European? Is ADVR applying to the French or EEC regulating bodies for their INDA equivalents? Do these regulating bodies simply accept FDA approval or do they require their own submissions?

Thanks