Australian newspaper article, page-198

....OK, why not, just waiting for the other half's plane to land, so here's some more food for thought.

FDA has 3 primary options open to it on the resubmission. What, you say, how can there be 3? It's either go or nogo, yes?

No.

A. So, door #1 has the car i.e. FDA accepts the resubmission as sufficiently complete to be reviewed, hits the chess timer button (as of the date of receipt of the paperwork) & the review clock for a new cycle starts ticking down.

B. And door #2 has the goat. Yep. FDA engages gears & lets us know that it is deciding to refuse to file the resubmission. It says to us that the resubmission is missing important stuff. What it doesn't say, but which is true, is that it has its nose decidedly out of joint over something. This is a serious thing for it to do (Govt in-house lawyers have to be notified), & only happens a few times a year at most, but FDA can & will do it if it thinks things are out of hand. So, probably not the case here, eh?

C. And then there's door #3. And here's where it gets interestingly vague - Bill**, the relevant RPM at the FDA looks at the resubmission, thinks hang on a sec, this is missing something necessary but it can be fixed quickly (e.g. the staple holding Appendix F-HH1x fell out on the way in from the postbox). He then gets on the phone or email to the relevant sponsor and says "Your staple fell out & Appendix F-HH1x has gone missing. Can you fix it pronto". And so the chess timer button doesn't get hit, & everyone waits until FDA says its happy that the apparently complete extra copy of the Appendix has been delivered.

This is analogous to the Christian idea of 'being in Limbo' - neither still in the old BLA review cycle, nor yet firmly in the new BLA review cycle. It's a vague state not well-covered by SOPPs or MAPs published by FDA, and I'm sure the speed with which sponsors transition it is dependent in no small part on the good relations they've been able to build with FDA personnel, especially the review team.

I hope Drs Rose and Krause use extra strong staples on this one.

** Not his/her actual name...or is it?

Cheers
GLTA(LT)H