Like I said though, that's just my unscientific opinion.
Although the FDA considers the recommendations of the AADPAC, the recommendations by the panel are non-binding. The final decision regarding pending regulatory actions for a product is made by the FDA.
"We appreciated this opportunity to present an in depth overview of our POSIMIR data and discuss it with the committee," stated James E. Brown, President and CEO of DURECT. "We are encouraged by the support from a number of the Committee members. We continue to believe the data meets all of the regulatory requirements and that the weight of the evidence supports approval. We look forward to working with the agency as it completes its review of the POSIMIR application."
https://ih.advfn.com/stock-market/NASDAQ/durect-DRRX/stock-news/81550685/durect-corporation-announces-outcome-of-fda-adviso
"Perfection is not attainable, but if we chase perfection we can catch
excellence." Vince Lombardi
Do your research! Play the TA. All posts are my opinion.
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