PAR 0.00% 22.5¢ paradigm biopharmaceuticals limited..

The novel drug - A DMOAD approach, page-30

  1. 1,784 Posts.
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    Well identified, Torpy. This is really worth listening to again and again. And I also agree that Marco's recent anecdote about his due diligence gave further encouragement.

    One other point which Mozz reminded me of once, is that even if a research lab miraculously created a perfect biosimilar copy of Bene's PPS, and then if they spend the years required to take it through all trial phases, with all of the same agencies (FDA, EMA etc), and do all of this in the knowledge that they can't even sell it for OA in regions where PAR has patent cover - they will, along the way, also need to prove batch consistency. The FDA will have to be certain that they have the manufacturing capabilities to provide this consistency in mass production. This is another massive mountain to get over. How many years of auditing and testing will that take? Bene have been producing theirs since 1947. How does a new producer catch up with that know-how? In your audio clip Paul suggests we'll have an estimated 10-15 years head-start. I actually think that's a bearish scenario. Personally, I don't think anyone will be able to do it, ever.

    I did a post a while back about the IP protection the Bene deal gives us, and the kind of outfit Bene are: 57359282

    When PAR recently spanked Morgans in the town square, their announcement stated that our supply deal with Bene gave us protection equal to that of a composition of matter patent for Bene's product. We could not be sitting any prettier.
 
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