Saturday, May 05, 2012 8:27:05 AM
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.
Kona Gold Beverage, Inc. Updates Multi-Million Dollar Merger and Posts Over $1.2 Million in Q3 Revenues • KGKG • Nov 15, 2024 10:36 AM
HealthLynked Corp. Announces Third Quarter and Year-to-Date 2024 Results with Strategic Restructuring, Third-Party Debt Repayment, and Core Technology Focus • HLYK • Nov 15, 2024 8:00 AM
Alliance Creative Group (ACGX) Releases Q3 2024 Financial and Disclosure Report with an increase of over 100% in Net Income for 1st 9 months of 2024 vs 2023 • ACGX • Nov 14, 2024 8:30 AM
Unitronix Corp. Publishes Its Cryptocurrency Portfolio Strategy • UTRX • Nov 14, 2024 8:05 AM
Avant Technologies and Ainnova Tech Form Joint Venture to Advance Early Disease Detection Using Artificial Intelligence • AVAI • Nov 12, 2024 9:00 AM
Swifty Global Announces Launch of Swifty Sports IE, Expanding Sports Betting and Casino Services in the Irish Market • DRCR • Nov 12, 2024 9:00 AM