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pinhigh

02/17/19 8:05 AM

#171583 RE: Daytime_Lantern #171580

DL..The gender bias thing was a wicked curve ball tossed Biel's way. Biel has expressed confidence in their adjustments this go round. Hopefully the process will be hurried along. Go Biel$$$

gimmee greenbacks

02/17/19 9:03 AM

#171589 RE: Daytime_Lantern #171580

My take away from your post DL is that you are very optimistic about BIEL getting FDA approval this time. Good to hear !

" They know exactly what the FDA expects, in the manner of document configuration and content. So, IMO, regarding the recent 510(k) submissions, that process should have been largely an exercise in cut-&-paste. The data is already there, but as I understand it, the trial metrics associated with men would be strip away, and the remaining trial data would be correlate to be women centric. Of course, it’s a given, that BIEL's folks are intimately familiar with that data, thus, in its relevancy and its idiosyncrasies. "

$BIEL$$$

Steve43

02/17/19 9:34 AM

#171590 RE: Daytime_Lantern #171580

It's funny how we hear how arduous things are for this Company. Lets see, the the Company supposedly set in place a News Media Network of 100 outlets by sending 1000 samples to them. This was done months and months ago, now what was its purpose? Everyone skips around that event, as if it didn't happen. Does anybody realize all the events involving the Company's progress, that have taken place since the mysterious 1000 sample shipment took place? Have we forgotten the Dr Oz 10 mins of exposure of the products to the U.S. general Public, and what the "immediate" response was from the viewing public? Count the Company's News Worthy items that have taken place in the middle of the "OPIOID CRISIS". This is BS, pure and simple. How "arduous is it to pick up the muckin phone and reconnect with those 100 outlets? We're in the pps toilet when we should already be in the pennies, so why aren't we? FDA ? BS to that argument, we are in the Global Arena and have been for years, might I say, "without" FDA. We have two cleared products for two years in the U.S., and might I add we have been in the U.S. for a multiple of years with prescription access. So why do we swirl in the pps toilet, the answer is simple, Management put us here. Two separate Multi Million Dollar Markets one on the human side with the other in the lucrative Pet World. So what's the obvious answer to why we swirl in the toilet? Market perception, of the Company. Good/great products in the hands of bad Management, for too many years. Just my opinion. Have a great day. Arduous, that's funny. Where is Smart Insole, where are the three big orders?