Was Allay rejected in 2009 using this clinical study with 91 women? The results of clinical are very impressive for Allay. Are you suggesting the FDA didn't really understand PEMF back then? If this clinical was an accurate representation efficacy wise, Allay is going to get through one of these days. Go Biel$$$
I would not say rejected ALLAY back then but the story was much more complicated back then as the product category was Class III, the story is very different after the reclassification in late 2015. Thus, I see no reason why BIEL could not use the completed clinical trial for Allay involving 91 WOMEN and luckily only WOMEN to submit a 510K.
that 2013 Allay study was conducted by Barry the Plastic Surgeon. I think the FDA would simply laugh at a clinical trial for menstrual pain where the PI was a plastic surgeon.
And those results look VERY suspicious. on Day 1, the control group experienced an AVERAGE pain level of 8.3 on the 10-point VAS scale? Really? an average of 8.3? the number 8 means "dreadful, intense, horrible" pain... "bulged eyes, audible screams, intense fear..." UNBEARABLE....
Barry claimed "A total of ninety-one (91) women were enrolled with moderately to severe dysmenorrhea." But the entire control group had an average pain VAS rating that was higher than 8 on the first day? That's not "moderate." That's not even "severe" -- that's DEBILITATING PAIN.
No, something is VERY wrong with the results of that study. I don't know why this plastic surgeon is conducting clinical trials for menstrual pain or migraine headaches but I don't see his results being useful in an FDA submission.
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