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Drugdoctor

09/15/12 10:12 AM

#26514 RE: soccadoc #26513

In the last conference call, the question was asked if the HK drug was likely an opiod drug, and I believe I heard a positive response to that question, so I don't believe it will be a bromphen product.

However the company could very well be Advance, looking to get into the USA market with an opiod.

The bromphen product was why I initially suspected Advance Pharma might be the product, but when we learned it was likely an opiod, I then realized it could be any of many HK manufacturers...

Always worth a few weekend thoughts though.
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lasers

09/15/12 10:53 AM

#26515 RE: soccadoc #26513

soccadoc

Elite is currently doing the R&D for ECR on the CR Lodrane 24D which will be for a NDA approval.

It is very unlikely that Elite would be legally allowed to undertake the R&D for a potential competitor "Lodrane" product.

The original Lodrane® 12D and 24D were discontinued by the FDA not because of the active ingredients brompheniramine maleate and pseudoephedrine hydrochloride. The products were discontinued because of Elite's CR polymer, for the 12Hr and 24Hr, that had never been FDA clinically tested to be reliable against body fluids and therefore not cause dose dumping.

IMO the new Elite/ECR Lodrane 24D will likely be tested as an ELI-154 NDA 505b2.