Someone posted this not that long ago. I found it useful,...

Someone posted this not that long ago. I found it useful, especially in how it characterised the second CRL as quite possibly a “soft rejection”. If you haven’t got the time, skip to the conclusion which is very useful, but best to read the whole report:

https://************.com/article/4645951-holding-the-fort-mesoblasts-path-towards-overcoming-fda-rejection

Type in seekingalpha

If you google Bloomberg FDA generic drug testing, you should see an article in the last day or two about how and why, at least in generic drugs, the agency have wanted to keep quality control in the manufacturers’ domain. It seems that they simply do not have enough resources to police things. Would it quite possibly be the same reason or one of the reasons why the CMC quality control hurdle also has to be very high in other types of biologic development, such as in cell therapies? It just sheds a new light on their request for extra data.