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Tuesday, July 28, 2015 9:47:02 PM
It's so easy to see if you read carefully. Everyone should go back and read every PR about Rexista. If it doesn't mention PODRAS then it is talking about the old formulation without PODRAS. The old formulation is a simple mechanical barrier ADF. Maybe they would let that slide by without Phase 3, but I doubt it. Now add PODRAS and you've added a completely novel mechanism of biochemical activation and/or deactivation. Companies have been trying and failing to develop this kind of technology for many years. The idea that an unproven, novel mechanism like this is going to be allowed to skip Phase 3 is farcical. The reason IPCI is not being up front about this is because Rexista with PODRAS is 2-3 years and $25-50 million away, even with Fast Track. If it gets approval, it will be one-of-a-kind best-in-class blockbuster of epic proportions just the way everyone thinks. But it is not six months away, and the company will need to raise $$ to get it done.
Mark this post. 2-3 years. $25-50 million.
"There are three kinds of lies: lies, damned lies, and statistics."
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