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Re: Sam81 post# 61346

Tuesday, 10/13/2015 9:28:53 AM

Tuesday, October 13, 2015 9:28:53 AM

Post# of 426266
Thanks Sam...good information and no doubt shares an insight into how settlement is viewed as an upside.

Interim confirmation in 2016 is no doubt an important factor leading to a broader indication prior to this look. No doubt some pushy investor would make the FDA look pretty smarmy if this wasn't the case.

Ex-USA deals will fund cash needs...more...rather than BIG IMO.

IMO US deal may be pushed back until after full RI...

JEFFERIES mentions ANCHOR impact....unclear if this is Anchor on or off label. IMO it would behoove FDA to grant on label and get First Guidelines out so they don't find themselves in court in a continuing basis.
***clearly this is off-label***. This is a calculated risk by FDA perhaps to mitigate legal exposure...a mistake IMO.

I don't expect 10-30 joint letter ends settlement...this is just the start of a long painful (for FDA) process.

Again thank you Sam for sharing your DD!

BB

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