G'day all.First post here. I'll post the same as I did on that...

G'day all.
First post here. I'll post the same as I did on that other board just down the road and on your right.
Yes the 900 page document would be great bedtime reading. I hope King & Spalding assisted with the preparation of it.
When they last represented Cellestis ( seem's like ages ago now ) and assisted them with the preparation of the company's PMA application and their presentation to the FDA Microbiology Advisory Panel. The FDA panel voted unanimously to approve the application and commented that "The PMA application and panel presentation was one of the best they had ever seen".
I've also noted that the next proposed meeting date of the Microbiology Advisory Panel has been cancelled (April 7th & 8th). Only going by what I've seen on the FDA site and this proposed date falls within the time frame of the 180 day supplement that was lodged.
Question then, As this is just a supplement does the Microbiology Advisory Panel have to have a formal meeting ?
Looks like they didn't want to get a speeding ticket slapped on them today after all ;-)
Cheers,
��
MD

PS. dr_d, Who's about to blow ?