Paradigm patent rejection, page-63

I'm afraid I can't answer who, outside of Paradigm, have a right of reference to Bene's Drug Master File.

The snippet below from Paradigm's original ASX prospectus shows that the right of reference was written into our original supply agreement. It has been difficult enough for Paradigm to get where we have WITH the ability to reference Bene's DMF and point to the safety and efficacy of their specific drug over a long period of time. The other vital thing that having supply of the Bene product gives us is batch consistency over decades, from a manufacturing plant which is routinely audited by the FDA.

Imagine you are a PPS manufacturer with a product not yet approved for human use, and an unaudited manufacturing plant, trying to get through all of the human safety and efficacy trials WITHOUT being able to reference Bene's records, whilst also trying to show that you can produce the drug consistently enough for FDA approval of human consumption? And you are pouring all of the time and money required into this in the knowledge that someone already has first-mover advantage, a Big Pharma partner, a decade long head start which begins with 3 years of FDA regulatory exclusivity, plus....finally....some patents to contend with which mean you cannot treat anyone with BMEL (which is a precursor to OA, and also a concomitant malady of OA). Would you even bother?




DJ Carmichael analyst report...