Sharewise Presentation 22/7/24, page-96

For any claim there needs to be a warrant to support it, then there is the question of whether the warrant covers all of the claim, if it doesn't the claim has to be cut back to fit.

When it comes to statistics, the FDA are the ones who decide where to draw the line. They are also the ones who phrase challenges on efficacy or safety or dosage, so you might infer that in effect they determine the warrants to be satisfied for any claims that might be made for what is put on a label. That after all is what we want to get to, a product in the market.

Whatever has happened in the past, when we get the FDA response, hopefully soon, all of that will become much clearer and PAR can tie down what is specific project-wise that has to be done to get closure.

So from my point of view if it is going to cost $100m to get there and that is an injection from a partner, then so be it. Do the deal.
IMO. DYOR.