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boi568

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boi568

Re: scorman1 post# 437701

Tuesday, 10/31/2023 2:21:12 PM

Tuesday, October 31, 2023 2:21:12 PM

Post# of 517472
From your own recitation, a SPA is not a requirement for a clinical trial. It is akin to technical assistance being offered by the FDA to companies intending to submit an NDA. As such, as I wrote previously, it will be most useful to companies in need of such assistance, apparently including SAVA. Companies that already know how design trials without FDA help will not need this form of technical assistance.
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