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Re: fuja21 post# 21423

Saturday, 05/05/2012 8:27:05 AM

Saturday, May 05, 2012 8:27:05 AM

Post# of 335383
After reading the flurry of posts responding to the letter to shareholders, it is very clear to me that (a) the investors are a very articulate group, and (b)the company appropriately consulted with legal counsel very quickly and counsel prepared the letter with them.

Clearly, the letter does not read as Mr. Whelan speaks, as compared to the recent interview. To be fair, I understand speaking 'on your feet', as it were, in an on-air interview, as he was, is far different than having the time to consider a detailed letter carefully, but counsel had a major hand in that letter and will be stickhandling dialogue with the FDA.

Based on my knowledge of another very slight FDA error, I am totally confident that the company will bring in the necessary warriors to deal with the necessary fire-fighting and corrective needs of this matter. It's logical and it's businesslike to do so. And there are warriors out there who specialize in nothing else but the legalities and intricacies of FDA processes and approvals. I asked a senior partner at our lead law firm and that's the answer I got.

Worst case scenario, in my mind, is for ALLAY to initially only get some sort of restrictive approval to get it out in the marketplace to help millions of women suffering from the debillitating pain and cramping of menstruation. Then, once it's out there, the company would apply for other, more liberal, classifications. Will this happen? As a laymen, it doesn't 'feel' to me it will get to the worst-case, multiple step, drawn out process, but what do I know? . My gut tells me FDA reviewers missed something and it will be corrected. I was advised it has happened many times before and will continue to happen, because of the complexities of the work the FDA carries out where often major decisions can turn one way or another on a single word, or miniscule interpretation.