Bobsee - Agree. There is a balance requiredWeazel - Valid point,...

Bobsee - Agree. There is a balance required


Weazel - Valid point, it's more complex than we may think, well at least I might think! There are lots of factors here. I liked PR telling us today that we have kept the potential commercial parties on hold till we get the Green light effectively. Makes sense but nice to hear it and get an update.



MixedBag - Yes also agree with your comments. Also, at least from a statistical point of view; that n has dropped due to SS achieved in 005 and 008. It's new data but it's also a stat. plan based on concrete data. It is up to the Sponsor together with the Bio Statistician to formulate that plan and submit it to FDA. The onus is on the sponsor, if they get it wrong it's the sponsor that will pay the consequences.

PAR would definitely have discussed the duration again based on observations from 008 for example. Yes it's a pivot to add in these changes, but in my eyes will be worth the wait. *fingers crossed*.

No doubt it will take some time to go through all areas of this draft protocol and all the new data that's been generated, hopefully not months as Paul also hopes.