I think the news will be that the FDA announces the design of the Phase 3 clinical trials, in reality that news should come as no surprise and is really already baked into the price, but who knows how the market will react!
As predicted, path forward for Phase 3 trials, all good, need to do the 2 separate trials, CR of $35m, not even bothering to go to retail investors, CR at $1.30 for Instro & sophisticated investors. Not many companies could pull that off in times like these! Annoyed at missing out, but happy with the progress.
I guess the thing investors in PAR have to remember is that its likely nearly 3 years before commercial sales are likely on scale. The Phase 3 trials will take the best part of 2 years to see much meaningful data. Of course in the meantime its not improbable that a Big Pharma will buy PAR out. My point is that patience is needed and a lot can still go wrong, so position sizing is important. I hold as much as I am comfortable with currently, may look to add as the Phase 3 data flows.
• Paradigm’s IND application to commence its phase 3 pivotal clinical trial investigating Pentosan Polysulphate Sodium (PPS) for the treatment of pain associated with knee osteoarthritis has been cleared by the US FDA.
• The US central ethics committee has already approved the Trial.
• Australian ethics approval for the Trial was previously announced on 24 September 2021.
• Approximately 65 sites have been identified throughout the US and Australia. Contracting with many of those sites has been completed. The first 4 sites in Australia have initiated screening participants. Screening at the US sites is expected to begin prior to the end of CY2021.
• The Company is now in a position to accelerate recruitment by adding approximately 10 sites in the United Kingdom and Europe, with site initiation and subject screening expected to commence in 1H CY 2022.
Good news, but not unexpected, we knew it was very close to approval. It does de risk PAR a little, so I expect there will be some movement up in the price as new investors look to build positions. I may look to add some more myself.
Stage 3 trials underway for a while now, some positive news around patents and other trials has been welcome news recently. In the last week someone or some people, have decided they want in, everything getting soaked up and price just going up as supply dries up. Its snuck up over 60% over the last week - mainly in moves of around 10% per day. Either there is some news not yet in the public arena or it has caught the attention of somebody who was previously unaware of it. I guess the other possibility is its been pumped somewhere online and its just speculative traders - but it doesn't seem like the sort of company they would normally play with?