RE:RE:RE:Quick questionNo way its "approval in March 2020".
BLA standard review process is 10 months typically; 6 months if you get priority review. Latest corporate presentation the "Filing
expected to be under priority review". Even LMNL is not sure if its standard or priority review process.
FDA process checks need to be added and new batches provided to FDA before they can submit amended BLA. Has anyone heard if the new process checks are completed? Only two years and still waiting. I am sure they will provide a NR when they are finally figured out and then LMNL will probably give a date for new batches, followed by amended BLA.
It is still a long way off for approval and many things can happen to delay BLA submission.
funkshow wrote: Bla approval in March 2020 exactly 2 full years after we were told it's just a couple check points. No big deal. Incompetent!