Hi folks, apologies to all I've been trying to detox from all things share market. Partially successfully !!
. Myself and luckyphil1 had a very open Zoom hook up with Simon. I was really impressed by it as my personal concerns were the openness of the dialogue between the company and its shareholders.
The below responses to the posed questions are our interpretation of the conversation and have not been vetted by PAR. Please take it in the spirit it was intended, which is to provide good information to this forum.
Q1, Is it clearly defined from the FDA what will be required to get Zilosul classified as DMOAD and if so what are the expectations from the FDA for Zilosul to be classified?
The 30pax trial was merely to inform on pathway.
There is no FDA pathway established at this point in time. The primary endpoint in DMOAD however will have to be linked to clinical outcomes i.e. reduced pain and increased function.
Q2, When is Peer review of OA Phase 2 B going to be released? Is this imminent or is there a delay with this. If so, is it possible to get an idea as to the cause of the delay? We actually didn't ask this as we got talking about other topics one of which was Simon's introduction to the company via Andrew Walker's experiences and how Simon had benefitted in a similar way to Andrew.
Q3, There was an understanding that the NFL MRI results would be made public. Is this still the case? Or if not, why has this changed ?
From PAR’s perspective the NFL study was officially concluded on day 81. The prescribing doctors were going to assess the individual patients and fund their future MRI’s. PAR did not budget for nor fund this MRI follow up program.
Other:
General but at times detailed conversations around the first hand impacts on Simon and Andrew Walker which were excellent to hear. Simon assisted in the set up of data room. Overall we were impressed with openness of conversation.
We put to Simon whether we could get a regular HC question session going and suggested quarterly. He was going to come back to us on that. So we'll keep everybody informed and get a thread going if that comes to pass.
(20min delay)