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Re: dr_lowenstein post# 21664

Tuesday, 07/17/2012 6:08:22 PM

Tuesday, July 17, 2012 6:08:22 PM

Post# of 445271
No answer? Its an easy question

Do you have a link to their BE equivalency studies for generics and their 5052B studies because all you generally post is the ALO2 PH3 information which ironically the CEO addresses both companies products:

"I mean, if you look at the abuse resistant marketplace and the technologies that have been utilized, you have the biggest, which is Purdue with their OxyContin product, and that's basically a hard shell. It's theoretically harder to crush, but the reality is if you put it in the microwave for 20 more seconds, then you're right back where you started from.

You have pain therapeutics, with the gel and people putting in -- what is it, nicotine and caffeine? We are sort of a one off. I mean, Embeda is a sort of the closest, but the difference there is that it's a one beat system. So you have the opioid and the agonist on the same bead, and that's why they have the manufacturing problems that they have. It's difficult to do all on one bead.

What we've done is just separate them into two different beads. I mean, that's why we are excited about it. It's different. Quite frankly, it's much more straightforward, and it uses the pharmacologic approach, which clearly the FDA likes the best, because it's understandable in terms of the science. Okay?
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