The "problem" is that BMRN has less adverse effects than Hemlibra..
and not working in every patient is not the same as an adverse effect..
In the FDA mind, BMRN drug could be better than current standard of care because it lasts longer than current standard of care and reduces factor consumption and bleeds in even the hardest to treat hemophiliacs..regardless of whether SGMO drug comes out possibly 2 years later and is better..
Which is why it will be approved as long as it proves its manufacturing is fine..
Reimbursement by insurance and patients wanting to use it, is a completely different story..