BOT 2.90% 33.5¢ botanix pharmaceuticals ltd

How did BOT eff up? they submitted the pamphlet to the FDA for...

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    How did BOT eff up? they submitted the pamphlet to the FDA for review during labeling discussions... only for the FDA to then find issues when doing the final review.

    All the information the FDA wanted is already there, but the FDA want it on the box as well, and they want the pamphlet to fold a different way.

    This is equivalent to knocking a drug back because of a single type.
    Last edited by Jonotr0n: 26/09/23
 
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