What is GSK Thinking With Its Latest NDA? [View article]
Eben,
It might be prudent to examine the total body of clinical work before rendering a negative opinion on Promacta or GSK. The FDA's outside advisory board of learned clinicians opined a positive outlook about Promacta with respect to ITP. Historically, the FDA follows the guidance of the advisory board.
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Eben,
May 30 16:58 pm
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All Comments by Rocco Verducci »What is GSK Thinking With Its Latest NDA? [View article]
It might be prudent to examine the total body of clinical work before rendering a negative opinion on Promacta or GSK. The FDA's outside advisory board of learned clinicians opined a positive outlook about Promacta with respect to ITP. Historically, the FDA follows the guidance of the advisory board.
Sincerely,