A delay in approval of a drug after presentation of an oral explanation is not uncommon, but it also appears that many drugs are approved by the end of that CHMP meeting. It has only been with the 102 submission that I began to follow CHMP proceedings. It seems to me that when a decision does not occur at the time of the oral explanation meeting, at least a 2 month delay ensues. It will not be until after the June meeting that CHMP will provide any minutes on the May meeting. HR (or whoever presents at UBS) could provide an update, but HR is not very forthcoming when news is unfavorable. HR seemed certain that the written responses to CHMP's questions and the oral explanation would lead to a quick approval. Again, my experience with CHMP proceedings are limited, so maybe an approval will occur before the July meeting.
Because Roche's Tecentriq recently failed its confirmatory trial for its bladder cancer AA, I question whether NKTR will go through with the Propel trial. Since 214 is not approved, I believe it becomes more difficult for NKTR to run a 214 combo with Tecentriq to treat bladder cancer patients. Tagliaferri stated at the Q1 call that 214 would be tested with Tecentriq's 2 "on-label indications" (bladder and lung C), and the bladder C AA will likely be revoked in the not too distant future. Given AZN's recent success with its PD1-L1 competing treatment Imfinzi -- 2 recent approvals -- my preference would be for NKTR to switch to Imfinzi. In contrast to Roche, AZN does not have any IL-2 competitors to 214, and it has been a great partner on Movantik.
Lastly, I may rebuild some of my NKTR position prior to ASCO. The initial 214 abstract data are sparse but encouraging. I will have more to say after the UBS presentation.