Did I miss a chapter 7up?
By my count, the close of comments as at May 21st plus 60 days takes the timing to July 20th, not August 14th. Seems to me that August 14th would be 85 days?
A possible danger of course is using the factor that 50% of reviews are completed in 60 days. I would not make the assumption that this would happen within that 50%/60 day period - it's too optimistic.
If we knew that 90% of cases are resolved in, say, 90 days, that might be a better speculation as to probability. Of course, any such speculating must include the assumption that there will be no delays, no questions asked, no new avenues of research, etc., opened up. And, don't forget, summer vacations can delay issues what with the need to have various people sign off on approvals as well. I have found that life is rarely smooth sailing.
For some reason, I can't recall, I have the period Friday July 25th to August 22nd highlighted in my schedule as possible FDA issuance period of its Order on the new Class II it's proposing "on its own initiative". I would suggest that earlier than August 22nd would indicate that FDA is very serious about giving Americans the freedom to choose non-drug pain management that has proven beyond any shadow of doubt to have no negative side-effects and a high degree of efficacy. They are very bright, mostly highly competent people, they'll get er done and I expect the FDA management subscribe to the philosophy that it's not about who is right, but what is right. Given the attitude shifts in the media and DC about chemical painkillers, there is no pharma company on earth that is going to have any credibility to absurd positions like, "no, we don't think drug-free and side-effect free is the way to go, we think continuing on our current course of dangerous overprescribing of chemical drugs is the best way". No Chance
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