Phase 3 iPPS trial in Australia ?

My wife andI had a consultation with Dr Bloom at Box Hill earlier this week. I got sometreatment for an ongoing foot injury and during the consultation we enquiredfurther about my wifes PPS treatment for her knee which was done earlier thisyear. Unfortunately for my wife the PPS treatment has not provided her any painrelief. I asked Dr Bloom in his experience what percentage of patients do not feelany pain relief from PPS injections. Dr Bloom advised that approx. 10% do notget any pain relief or benefit from PPS.

On a separatematter I also mentioned to Dr Bloom that I have a friend who has OA in his knee.Dr Bloom advised that there will be another trial commencing in one or twomonths time which will include approx. 100 participants. He suggested that myfriend should contact the clinic and he could participate in the trial subject toan MRI. The trial will consist of approximately 100 patients and will be asplit of 25% placebo and 75% PPS. He advised it will be a free trial with no costto the participants. Dr Bloom advised the trial participants will be observed andfollowed up for several months after their treatment. Given that this study is placebo/iPPSit sounds like this will form part of the Phase 3 trial and will be under the SAS.

I didn’t realisethat the company was potentially planning to run a Phase 3 trial in Australia.This does seem to be consistent with the Coppo report from last night. Ie trialsin USA, Europe and Australia. @Mozzarc Master Mozz any comment on this ? We mightalso see some more exciting PAR announcements coming in the next few days…..Potentially re the release of WOMAC pain data for the 100 patients treatedunder the Special Access Scheme. As per the company announcement on page 5 ofthe April 6^th Cap raise documentation called “Release of FDA minutesfrom OA Pre-IND meeting, TGA SAS Womac Scores, $35M Placement” that AdditionalWOMAC Pain Scores on 100 patients from SAS will be released in Q3 2020.

Itwould also be nice to know what the actual Phase 3 primary endpoint target isin terms of WOMAC pain relief…