Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-182

Nice insights again Mozz,

My most recent thinking (and confirmed directly by PR in various updates) is iPPS key advantage over all current competitors is the fact it's multiple modes of action to systematically treat OA. From the paper I previous posted on:

"Recognising that this is a whole organ disease and realising that focusing on reducing damage to cartilage in and of itself is unlikely to lead to meaningful improvements in other joint tissue structures that are meaningfully involved in osteoarthritis (including the synovium, bone, meniscus and muscle) is important. .....Many of the agents being developed are focused on an intra-articular route of administration asopposed to systemic
pharmacotherapy" => UNTIL NOW

The multiple $B question is whether the FDA becomes accommodating and agrees upon fast tracking it to patients. In more specifically terms of labelling as part of NDA process, they may accept innovative surrogate DMOAD end points via ongoing monitoring (of PAR002 & 003 patients) post NDA/approval. They may also seek post approval confirmatory trials before allowing such labelling. I suspect it may require the latter post P3 trials at some point but this is hopefully where big pharma will play a pivotal role. Irrespective it won't matter as much by then as it will become a blockbuster beforehand.