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Friday, March 01, 2013 1:53:48 PM
Look at recent events and current status:
Public meeting Friday April 5 to discuss BIEL type devices, hosted by FDA;
Device space is still new at FDA, may not have skills in-house to assess;
Discussions with/at FDA are about how/what/where to designate BIEL products, not whether they are efficacious or safe;
Deal with Gro-Internationalaround Feb 14 to market in EU and Africa;
Gro-International owned and run by ex-P&G exec 25 years;
New J&J president is ex-director of J&J devices division;
DID you know this? EU folks take many drugs via suppository, via tissue absorption, rather than have the drugs going through their entire systems. They are light years ahead of us in terms of safety;
BIEL is a tiny company surviving by selling stock;
Products work extremely well, personal experience; and
Not one negative side-effect, ever.
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