DRRX . estas estimulantes palabras del CEO, son las que parece animaron la cotizacion ayer que cerro al alza, asi que parece que los dos proximos meses van a presentar de nuevo y logica volvera el run up pre-FDA por tanto veo oportunidad para entrar y sacarle algo de aqui a esa fecha pero despues , huuuf no se si pàsara como CHTP, aunque me inclino mas a pensar que a la 2ª va la vencida precisamente por que la preocupacion de la FDA sobre los estudidos de bioseguridad de POSIDUR ( Bupivacaina ) no parecen graves. Con dilucion reciente y para un plazo de dos meses tampoco parece que se aplique otra.
http://seekingalpha.com/article/2023771-durects-ceo-hosts-posidur-update-conference-transcript?source=google_news
In the Complete Response Letter, the FDA had no comments with regard to efficacy or cardiovascular safety concerns. They had no concerns on the CMC section, non-clinical the pharmacology or other sections of the NDA.
As we’ve just received the Complete Response Letter, we need time to evaluate the FDA’s issue and we’ll seek a meeting with them. I hope that within the next 60 days or so.
I can’t help briefly expressing some frustration and disappointment. We feel we ran a vigorous development program and that a delay in getting this drug to market means a lot of patients, who would benefit will have to wait.
I and my colleagues at DURECT, all feel this is definitely a product we want to love one to get if they face surgery in order to minimize the post-surgical pain and reduce the need for opioids.
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I’d also like to note that we have multiple patents that go out to 2031, so there would be a long period for our shareholders to gain a return from Remoxy.