Replies to post #961 on Durect (DRRX)

[DR. EVIL]

Understood. Thanks.

[BooDog]

Just my non scientific opinion... I would think POSIMIR® would need to clearly show a benefit to the patients. Enough so that it would compete against the SOC (standard of care). If it is, it would penetrate the market and make a profit. IT MAY get approved, but I'm not seeing it close in on the competition enough that surgeons would reach for it.

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

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The FDA makes the final decision. This vote is intended to give them guidance but they are free to completely ignore it if they choose (at least that’s my understanding). I don’t like the degree to which the fda committee members opposed. Not sure I get warm and fuzzies from this.