Thanks Vasilios Yes I believe I have read this text. I guess I...

Thanks Vasilios

Yes I believe I have read this text. I guess I wanted to see a definitive statement from the FDA to state exactly what they want - ie defined Action Item. Rather we have another general assumption about what they may need.

Again, we would have expected the FDA to raise this issue prior to second assessment and also mention the BLA as incomplete.

It’s very smelly to me this whole issue.

It’s either government process incompetence in not being definitive in their needs or there is just no data for the assays at all - which would seem odd to not have the data.

MSB claim to have it and will be submitted - we then need to wait to see if the alleged “government process” is satisfied.

Definitely seems like the old - govt says thanks but ohhh now we found something else we want to see in this next review ….as basically they disorganised and incompetent. I have been on that roller coaster a few times before with govt agencies and it is really the definition of insanity.