Oppenheimer 29th Annual Healthcare Conference CC
Just a couple thoughts
- It’s good to understand that the Rolontis issues are not drug manufacturing validation related (ID test methods, critical manufacturing test methods, GMP quality (stability, retains, etc), batch validation campaigns, etc . That would really had taken a decent chunk of time to take care of. Redoing Summaries should be the easy part, at least it’s not the rate limiting step. As it is, I see a good 4, probably 5-month process before they can submit the BLA again. Take the shipping validation; you probably need a month to put together/approve a shipping validation protocol, a month or more to ship the samples, test the samples, and another month to put the validation report together and sign off on it (and summarize that in the BLA). Take some time off that timeline if they have their act together (it would be nice but I don’t think so) and add more if they don’t. It could get complicated w shipping validation e.g. who tests the shipped samples if there’s no approved CRO testing lab in the US? Or is the shipping validation intended for final product sent from Korea (that means that Hanmi is the packager for the final presentation and not just bulk drug) so do you send it back to Korea by boat (LOL) if no approved contract lab in the US or is it for the final presentation shipped within the US (that means Spectrum already has a contract packager and contract lab) etc etc etc (Ok, I'll stop w the musings)
Anyhoozle, they did themselves a favor by adding color to what was needed to be done.
- Who dropped the ball on the Rolontis BLA delay? This was in the Regulatory Affairs, Quality, and/or Technical groups domain. The only way you can blame this on upper management is they didn’t hire the right people or not enough people.
Anyhows, in many ways I see this as the glass half full. It’s a major lesson learned for when they file the pozi NDA.
- Interpretation of the Z20 cohort 1 being "potentially registrational". Simply means if the data is good, they can use it to get AA (from other CCs, this is what FL means when he states that pozi is already on an accelerated timeline even w/o BTD)
