Yup, not worth ruffling feather at the FDA, especi
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Posted On: 09/30/2019 7:38:16 PM
Yup, not worth ruffling feather at the FDA, especially since we are already getting the BTD treatment. The whole stability is over a dose that we did not think the FDA would be most interested in. If we were 100% in 700mg dose mode, I would think BTD would be applied for long ago and stability at that dose would have already been done. The results from the 525mg changed things and threw a curve ball.
The other reason I agree with not applying for BTD is the history of the FDA rejecting these application not because they are not deserving but because they decide it is un needed or some other reason. All we would have is the risk of a BTD application rejection based on the fact that it is of no time saving benefit, it would just look like a rejection in the PR.
The other reason I agree with not applying for BTD is the history of the FDA rejecting these application not because they are not deserving but because they decide it is un needed or some other reason. All we would have is the risk of a BTD application rejection based on the fact that it is of no time saving benefit, it would just look like a rejection in the PR.
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