It is common knowledge that the FDA will have questions that come up after an initial BLA submission. Anyone who has worked to get technology approved knows this will occur. I cannot imagine there being very many submissions that do not require follow up responses. Coming from 40 years in the medical business I am surprised we got a response so quickly from the FDA. I consider this a good sign.

I just spoke to a friend of mine who worked hand and hand with the FDA on product extension approvals in the Cardiovascular market and he stated it would take them a year, in many cases, to get a product extension for diagnostic imaging software. There were many questions back and forth that the FDA requires to make sure there are no mistakes that can hurt a patient.

These lawyers are bottom feeders in my opinion, very similar to ambulance chasers, and they should be ignored.- IMO