Gosh there is a fair bit to unpack...ok lets keep going:
He then stated as Dr Skerrett mentioned we have a number of activities to accelerate the P3 program. As a sponsor we need to constantly look at our recruitment rates and constantly see how we can improve these rates.
The sooner we get to the finish of Phase 3, the sooner we get to the discussions with the FDA and the sooner we get to the registration of the product, the sooner we get to those potential blockbuster revenues.
Its a very key focus for everyone at Paradigm to make sure we get those recruitment rates moving as fast as possible.
Commercial in confidence in motion, updates to come to shareholders in regards to commercial partnering.
EXPECTED NEWS FLOW
006 (extension study) commenced $7.4 million tax rebate received. Cash bal was approx. 93/94 mil at end of Sept, this is a useful addition to our cash balance. First DSMB report to come out by end of this quarter. Shareholders will be updated on this meeting, we aren't expecting any issues and are confident that the meeting will go well.
MPS VI (P2) - we hope to announce next month that it will be 100% recruited. Then follow up and read out.
End of Q1 next year will be a very important milestone for the company - 008 6 month read out.
MOZZ NOTE: This in my view will be highly pivotal but we need to be patient, I had originally thought it may be more like end Jan, I'm pushing it out now. Why? Because there is so much data to unpack...mate, it takes lil' ol Mozz 2 full days to summarise just a 2 hr AGM meeting...imagine the amounts of overlapping data in this very comprehensive trial, disseminating the material, deciding what needs to be announced and what needs to be published, how to convey the message and then start to think of relaying and organising meaningful discussions with the authority.
Wait...wrong..not just one authority! Europe as well potentially. Busy? They are going to be flat out but it will be terribly exciting.
"...this is not only synovial fluid biomarkers and pain and function but it also looks inside the joint with MRI to look at the status of the cartilage and also the underlying bone and of course the synovial tissue".
Canine 20 week follow up, that data will also be out H1 2023. Why do another study, we know it works in dogs and horses. This study is done in animals that have natural OA, they have symptomatic OS. We are looking at a whole range of measures and imaging inside the joint.
Natural OA in a dog is very similar to human OA. We are looking to see how it is tracking in the dogs and that's a nice way to see how it tracks in humans. 20 weeks =3 years. It is not an experimental model (and that doesn't always translate into humans). This is not the case, its a really good surrogate for what's happening in the humans.
We will also have data in pre clinical proof of concept of a mouse model of ARDS mediated by influenza infection - peer reviewed manuscript to be done by H1, 2023.
We will also have some further news about further IP.
We are also progressing our commercial discussions with our MPS asset.
MPS ASSET
MPS Asset is being largely being driven by Plexus.
MOZZ NOTE: This next point was a key learning for me:
It is very important from a futuristic point of view why we go with MPS first. There is some jurisdictions around the world that base pricing of new products that are registered are based on comparative prices.
MOZZ NOTE: So in other words, much easier and beneficial for us to determine the pricing on a higher priced product (that's related) eg for MPS and then go for pricing determination/setting for the lower.
Lets say we will achieve $50 - 75K for the MPS drug (over one year) (New guys, that isn't a typo, some ERT solutions sell for more than $300,000 per annum, look up Vimizim, ok I've done it for you, reference 7 below!), this should be done first before OA price setting. The other way around would potentially mean a more diminished pricing model for MPS.
Again, this is a further (real world!) example of how PAR are learning so much and implementing many ideas and concepts that we simply do not know about. Sure it is good to get some level of transparency but for commercial reasons this is not always possible. Long term holders love this. They don't care as much that we aren't privy to each and every discovery and point...a LOT is happening that we simply do not realise. My views totally.
The Meeting then turned to questions... We'll pick that up in Part 4.
AGM 2022
(20min delay)