Gday Poolboy.
Maybe a matter of time, but as we’ve discussed in depth before, there are no shortcuts for PPS rivals. If this isn’t Bene PPS, then one thing it shows is that the FDA have become satisfied with the batch consistency of another manufacturer (for their animal-products parameters anyway). However, to get approval for human use they’d still have to go through the same trials as PAR to show safety and efficacy of their drug. We know the cost and time that needs to be sunk into this journey for any hopeful - but as you’ve correctly stated, unlike PAR, if they achieve trial success they won’t get to sell it. PAR have patents covering major markets. These will no doubt be challenged if someone gets this far, but it’s another layer. We’ll also have 3 years’ regulatory exclusivity helping us to build market share with first mover advantage etc. However, I definitely think you have a point, and PAR can’t stuff around wasting any time if we get approval. Everything should be in place with our sales and distribution partner, ready to hit the ground running and aggressively capitalise on our advantage.
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