December 18, 2012


October 2, 2012 PR
The finer point of this press release and paragraph could be: "We look forward to formal review of the resultant protocol and supportive programmatic elements with FDA under the SPA process."

Has management truly (not technically) filed the SPA (i.e., filed for submission with no thought of withdrawing it)? If so, when (so we might apply the erstwhile "45-day clock")? I know not...

Receiving consensus for a Phase 3 SPA from the FDA is a 2012 company goal. While management gets the concerns of shareholders asking when the SPA will arrive, they seem unperturbed and unconcerned (i.e., not worried) about situation.

Maybe the 45-day clock, is like Barbossa's view of the Code of the Pirate Brethren: It's more what you'd call "guidelines" than actual rules. Welcome aboard the Black Pearl, Miss Turner...Arr!

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