Hi Moz - Back to your original post. Whilst we have been focusing on hearing news from the first 10 ex-NFL players under the needle, I have also been thinking about the strategic importance of the alliance with the PPEN network announced this time last year (below). Firstly the importance of this network in terms of recruiting for the IND applications and the Phase 3 trial (the approved IND was for treating 10 ex-NRL players who were identified in May, but a further 40 may be treated subject to future filings …. and who knows how many recruits will be needed for Phase 3). Secondly the importance in terms of promotion given the PPEN network has: 1) 11000 members - all high profile and all with elevated risk of OA (10/09/19 announcement states 3x risk in ex-NFL players); and 2) commitment to creating awareness of opioid epidemic. So I very much hope PPEN is as anxious to hear results from the first 10 ex-NRL patients as we are.
Extracts from relevant announcements
25 October 2018:
Paradigm is pleased to announce it has entered into a Heads of Agreement regarding a strategic partnership with the US based Pro Players’ Elite Network to assist with recruiting and commencing treatment of US based sportspeople, via their doctors, under a proposed FDA Expanded Access program commonly referred to as the ‘Compassionate Use’ program. The Pro Players’ Elite Network is a membership organization of over eleven thousand retired NFL players and elite athletes. The Pro Players Elite Network also has a charitable component to their network that is committed to creating awareness about the National opioid epidemic and the impact opioid pain medications have on professional athletes who suffer from the long-term effects of sport induced pain.
15 April 2019:
Up to 50 ex-NFL players in the US to be treated with iPPS for OA pain. Potential for significant media attention if treatment is successful
8 May 2019:
First 10 ex-NFL players identified, US doctors engaged
10 September:
First FDA IND cleared - Paradigm submitted an Expanded Access Investigational new drug application (IND) for pentosan polysulfate sodium (PPS) for the treatment of approximately 10 patients with pain associated with knee osteoarthritis (OA) with concurrent bone marrow lesions where patients have failed to respond to standard of care.….. In males under the age of 60, arthritis is over 3 times more prevalent in retired NFL playersthan in the general U.S. population.
(20min delay)