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Dear Agoracom Family,

I want to thank all of you for your patience with us over the past 48 hours and apologize for what was admittedly a botched launch of our new site.

As you can see, we have reverted back to the previous version of the site while we address multiple forum functionality flaws that inexplicably made their way into the launch.

To this end:

1.We have identified 8 fundamental but easily fixable flaws that will be corrected in the coming week, so that you can continue to use the forums exactly as you've been accustomed to.

2.Additionally we will also be implementing a couple of design improvements to "tighten up" the look and feel of the forums.

Have a great Sunday, especially those of you like me that are celebrating Orthodox Easter ... As well as those of you who are also like me and mourning another Maple Leafs Game 7 exit ... Ugggh!

Sincerely,

George et al

Message: Tweet from Prof Kausik Ray

100% agree with your balanced and reasoned response, Buckeyes.  

https://www.fda.gov/drugs/data-standards-manual-monographs/phase-4-commitment-category

"Phase 4 studies are post-marketing studies that are imposed upon a pharmaceutical firm as a condition for drug approval."

A mear month after reviewing BetOnMace, the FDA announced they want to loosen criteria to approve drugs for serious conditions.  If you read the proposals, which they specifically state are reflecting their current thinking, BetOnMace would receive immediate approval, and possibly with the condition of a Phase 4 which would be the worst case scenario under the new guidelines.

Anyone suggesting that a new Phase 3 trial will be required is presumably of the opinion that the FDA's current thinking will not be applied to the evaluation of BetOnMace.  https://www.fda.gov/media/133660/download

 JMHO

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