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2Relax

05/13/19 8:46 AM

#180312 RE: Daytime_Lantern #180306

This is why we should have never submit a 510(k) withilout GP. Your point about the lack of people who know about this product simply enable the FDA to continue slapping AW around (I'm beginning to think they [FDA] enjoy this part).

This could not happen with high level attornies who also used to be in the top tier of the FDA. They already know where all the bodies are buried, so they can speak on an even level with the FDA current top tier.

This is how it works but AW thinks hes gonna teach them a lesson and save money by not having GP represent BIEL. This is the very reason in my opinion he should step down and give the helm to someone who has more experience in the part of the process. I appreciate his tenacity to persevere this far, but he has now bumped his head and has nowhere else to turn.

Remember last year when he said they had to hire a consulting company to help navigate thru all the companies that were contacting them. (Not even one hint at what happened there).

Once we get GP to finish the FDA approvals which are needed to get the deals with the big box stores, because they simply cannot be sold without clearances (muscleskelital being the most important because it also include the entire back from what i've read), then hopefully we will also have an incentive in the deal for the retailers to begin an advertising campaign.

Once the advertising campaign begins we should see an immediate uptick in sales. This is where the real important part kicks in, the social media... twitter, FB, instagram, etc. And also keep the website current. If we already have a functioning social media base that can get excited and continuously keep the conversation not only moving forward but also EXCITING, this has a chance to take to medical community by storm. Well thought out strategy that continues to escape our fearful leader AW, who doesnt know what his next move should be.

Just very sad that someone can continue to make the same mistakes over and over again but still cant learn from past mistakes. Instead continues to act stubbornly just like a child.

Lets see if we can hopefully see anything positive in this next report, even though it continues to be NOT AUDITED... smh!

Only one thing left to add to this... TACT

pennytiger

05/13/19 8:46 AM

#180313 RE: Daytime_Lantern #180306

You are right DL, I've seen the FDA reverse course before due to public influence, one time in particular was a female sexual enhancement drug that the FDA had first rejected. Women protested, because there were no drugs on the market for them, and yet men had many to choose from. After the protest the FDA decided to approve the drug, with a black box warning. This is a case of women saying, let us make the choice, if there are side effects we will deal with them, but don't make the choice for us!

BIEL doesn't have the funds for mass marketing, and they can't seem to find a partner, or is unwilling to except a deal unless it is exactly what they want. It seems we have a leader that doesn't have the slights idea of how to build a brand. We know that because of the blunder that happened in England. And doing this makes public awareness more difficult, so yes is does seems like BIEL helping the FDA to keep Actipatch down!