Durect (DRRX)

[realfast95]

Transcript of the earnings call. The big surprise was the change in the
POSIMIR phase 3 study.

"We are in the process of implementing a request by the FDA to amend the protocol to move to an active control arm that will be bupivacaine."

"In addition to changing Exparel in this trial from Pacira to Bupivacaine, we are switching the primary efficacy endpoint which is going to remain pain on movement from 0 to 72 hours after surgery to 0 to 48 hours after surgery."


Analyst Annabel Samimy - Stifel Nicolaus - called him out on that.
His explanation seemed good. His off the cuff comments were much better than his prepared remarks from a presentation perspective. The transcript is much better to understand the status of the products.

"And as far as cost goes by doing it this way we're going to be probably in the maybe a $2 million so the cost the additional cost with regard to it. And timing wise you know we’re looking at six months difference from what our original timeline. So six months more $2 million more. We think at the end it will be a stronger package. It has to be about competition or not about competition but about potential business development."



http://seekingalpha.com/article/3994334-durects-drrx-ceo-jim-brown-q2-2016-results-earnings-call-transcript?part=single

However Investors are more interested in Remoxy.
That product will be renamed REMOXY ER (which stands for Extended Release)

The approval of REMOXY ER which would be DURECT's first pharmaceutical product and it has a September 25 PDUFA date.