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Wednesday, November 15, 2017 10:09:00 PM
505(b) was granted by the FDA. There is no smoke and mirrors. The 505(b) could potentially extend Prurisol exclusivity by up to 5 years I think. Do people understand what that means? I believe; In the final year on the market, let's say year 10 while making 2 billion a year will extend 5 years. While the % increase is a 10% year over year....it would be like $10.6 billion additional dollars made. I think that's a big deal.
Also not to mention the phase 3 trial is often less stringent so it will most likely cost less...less phase 3's less patient population equals cheaper and quicker to market.....that is very valuable in the real world.
Again. The FDA decided and granted.
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