This is only a step in the approval process, but it seems to indicate that NKTR-181 is still moving forward.
FDA accepts Nektar’s marketing application for low back pain opioid https://seekingalpha.com/news/3375355?source=ansh $NKTR
Still long NKTR for now
Gosh, I was holding thinking that 181 was “fast tracked” to approval, but the PR indicates the FDA wont respond until May 2019.
This is an application for approval of MATERIALS to market the drug (not the IND: investigational new drug application)and not an application for approval of the drug for use(the IND). So this is just part of the process of getting a drug approved for use and allowing for it to be marketed to some audience (clinicians/patients/etc). So in my view this is not a big deal. The actual IND review for use of the med in the desired indication IS the big deal and the answer to this request should be known in the fall (think a response is due in October, maybe?).
Thanks for pointing that out! I completely read right over that part. Very helpful.