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Monday, March 28, 2011 8:58:26 PM
1)Financials no later than April 15th.Delay due to the old accounting firm went out of business. New larger firm being used now.
2)New world wide distributor will be in place in a couple of weeks. This firm is large,with enough assets to promote and market products world wide.This distributor will be moving product into the retail markets.Distributor is asking for small packaging changes.
3)All information has been delivered to the FDA from their last De Novo Request for info.,Andy stated that they have answered all the FDA's questions and concerns.Andy feels that the FDA is close to making a decision.
4)Gel Less Standard TENS Rx: Relief of chronic intractable pain is about a week away from being filed. FDA advisor wanted some changes.
5)Major Phama is waited interested,and watching. Currently their are 4 Pharma companies focused on what BIEL is doing.
6)a German company is extremely interested in the new Heel Pain Therapy Kit. They have tested it and want it.Biel has around 15,000 units on hand to ship.
7)Biel has enough money to get thru the FDA process,so far no problems,of course the more money the more they can do.
Colorofmoney's...opinion is that when FDA approval hits,Andy will sell to big pharma or company soon after.The key is getting US approval.We will see.......... In the mean time,getting the new distributor and promoting the right way to the world wide market is also highly important.
***Please always do your own DD!
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