Replies to post #181564 on Bioelectronics Corp (BIEL)

[Steve43]

The good news is AW is on the ropes the anger displayed in the last days can't be quelled with BS anymore, action needs to take place, He needs, and I feel he has no choice but to update shareholders now on CVS, VA, NHS B.Braun etc, etc, etc, he needs to come clean. JMHO Enjoy your day. I'm starting to feel optimistic that things will be clarified, soon, very soon.

[beacham]

“In our last interaction with the FDA, their staff were very receptive to the idea of using data from the neck osteoarthritis study to seek general indications for both men and women. The neck osteoarthritis study represents our largest sample size and provides robust clinical evidence that the ActiPatch reduced pain better than a prescription NSAID. We are confident that the FDA will view this data favorably and help us get to the finish line of getting clearance for general musculoskeletal pain. We intend to submit the new 510(k) application within the next few weeks”

Hell, yeah, I'm gonna blow the whistle of 'I told you so!!!!'. What kind of stupid game are we playing??? This is ridiculous. Time and money down the drain. If we knew or had a pretty good idea this study was to produce results enabling a submission for full musculo-skeletal, then why ... I want to scream at somebody and throw something or slam a door. There is no excuse for this.

msg #163558 from 05 Dec 2018 - By immediately re-submitting for women only, we are validating their nonsense (gender diff?). It shows weakness and fear, as if we are conceding we have no choice. Don’t fall into the trap by playing their stupid game. We don’t have the time or resources for a goose chase with limited upside. It seems finances are tight. We need to work smart, not like scared rats running thru a maze.

Instead, submit for Allay and Post Operative RecoveryRx. We have the data and are ready to go. Put this full body on the back burner for the foreseeable future. Meanwhile, strongly (and loudly) support all the other initiatives and get the ball rolling with Veterans Admin, CVS, B Braun, Evomed, MundiPharma & PainGear. Come back to the full body stuff when we can fully fund a large study, then submit including all the previous data. Then let’s see what happens.

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So, now, at a minimum, it's 90 days more if all goes perfectly with the submission which has not been done yet. Fat chance. Dollars to donuts the FDA requests yet more info stopping the clock some more. Where does it end? Are we going in with Goodwin & Proctor or are we to put on our sunday-go-to-meetin'-clothes, polish our shoes and hope for the best???

Maybe the FDA will grow a pair. I doubt it. Maybe the decision will be expedited and will render an approval in a few weeks. Again, I doubt it. However, should it happen I will be one happy camper and will gladly enjoy a healthy slice of humble pie.

This has become a full fledged, unvarnished ****show. Whoever reads this ... if you are planning something ... large investor activist ... now is the time ... Not selling anytime soon but something is very wrong ...

venting is healthy, WBeacham