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Biotech / Medical : Apricus Biosciences
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To: eico20 who wrote (2020)8/20/2016 12:00:52 PM
From: eico20   of 2026
 
It seems to me the Type B meeting serves 2 purposes:

1. To improve or speed up the approval chances or avoid delays

I've seen many NDA submissions with much less data and certainty than Vitraos has at this point, specifically because the efficacy and manufacturing issues are resolved. Vitaros only has to prove safety with DDAIP, and so far:

1 million individual patients who have been prescribed/purchased at least 1 Rx of Vitaros. And separately, Apricus will use data on 1 million doses worth of sales for NDA resubmission safety data.

2. To help move the share price up. Because feedback from a Type B meeting can be reported as a PR to boost the PPS, a regular submission without that feedback is often not reacted to.
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