Ann: PARADIGM REPORTS IND APPLICATION UPDATE, page-121

Mozz had pointed out previously that, this time, the FDA could only raise issues with the subjects they had previously raised (i.e. the 6 questions).

We are now down to 1 question, and we've been given good detail on what it relates to. Presumably, this now represents the only part of our 30,000-page OA IND application which the FDA can/will seek any further clarity on. The rest of it, all of it, has been accepted.

The PAR team have got us 99.9% there. Fingers crossed their confidence in reassuring the FDA on the tissue issue of that single rat, using existing data, is not misplaced. Assuming it is not, we're off.

I understand that delays cost money, but I don't think investors in PAR at this stage should be overly concerned about dilution. If a CR comes, it comes. It's part and parcel of investing in pre-rev companies. Considering the scale of the prize on offer, the infinitely more important thing here is to be patient, and provide everything the FDA want.

I'll stop short of calling the opening of Para_002 a fait accompli, but it is now only one step away.