Mate, you have called me a sucker and a surrogate before.
How many childish names you going to spit out? Do you think you are going to win a scientific based argument based on that?
I only wish I had a few days to respond to your post. There are more holes in it than those crazy $3.50 sponges from woolies that I need to keep replacing every few weeks yeah?
I honestly do not have the time to argue each of your points, so I wont. I will give you a few, and you can come back when you can.
a licence for rhinitis (blocked nose). Clinical trials failed.This is not just a blocked nose, that's a symptom, its an allergy, it's caused from a release of histamine from the body, it is inflammatory.
This failed because of the route of administration, it was not at high enough absorption via a nasal spray. What you have totally missed is that it gets addressed by a different route of administration, namely Sub Q.
Histamine production is not only inflammatory, it is a potent inflammatory mediator
1 . Why aren't you stating this in your argument?
BMEoften resolves spontaneouslyThis might be true, but it is more like some...ie in some cases. There are a lot of cases where BME's are a causation for serious structural damage. These are the ones we are addressing.
There is a definite association, this excerpt from the Osteoarthritis and Cartilage Journal:
"Osteoarthritis associated bone marrow edema-like signal lesions
are an expression of a number of non characteristic histologic abnormalities that include bone marrow necrosis,
bone marrow fibrosis, and trabeculae abnormalities. Moreover, subchondral cystic lesions appear as well-defined
areas of fluid signal on magnetic resonance imaging (MRI) corresponding to well-defined areas of lucency with
sclerotic margins on radiography. Subchondral cysts are known to be associated with osteoarthritis".
2Quite simply BME's depict the very symptoms we address:
"Bone marrow edema lesions (BMEL) are changes that occur in the subchondral bone and are detected by MRI depicting the severity of symptoms including pain and cartilage degeneration in osteoarthritic patients."
3Firstly,PAR didnot carry out a well organisedand compliantprotocol for dose responsefor PPS inOAwhich was the responsibility ofDS,whoisthehighly paidregulatory affairs“expert”atPAR.This dosing study was at the insistence of the FDA. What makes you think it wasn't well organised?
Slow FDA responses may be slow as the refusal toapproveprogressto Phase 3 clinicalrequiresdetailedlegalargumentandcarefulexplanationof serious procedural deficienciesSo if we eventually get FDA approval to commence our P3 based on current revised protocols, you will admit there haven't been any serious procedural deficiencies and it took some time as there was so much good data to go through and the fact that n and 12 month dosing has been accepted is the ultimate in P3 sanctioning for PAR?
Thisdecisionappeared to be guided by PR,whothenmarketedPPS as a solution for the US “opioidcrisis” to the FDA, a hurdle they do not seem to have achieved.Again, we need proof of this, where are you getting this impression from? You are inferring that we are not addressing pain to the same extent of opioids and certainly we have no better safety profile as these opioids?
This is totally false. Need to see your references and sourcing on this. Opioids for instance give an average of circa 15% reduction, our data is circa 65% achieving greater than 50% reduction, iPPS is non addictive. Opioids can be highly addictive for a significant proportion that are on them.
If this hurdle hasn't been achieved, how did we achieve a Fast Track designation? The drug clearly works and is addressing a Serious and Unmet need.
Thirdly PAR focussed on “Disease modification” at great expenseand distraction.Itmay betoo difficult forregulatory authorities to approveclaimsfromearly investigationswith inadequate numbers,reproducibility,and validated criteria.Complete rubbish.
DM is not a distraction it will be become one of the most sought after redeeming features of our drug. The objective evidence via Quant MRI was testimony of how well our drug performs and what it can do within just 6 months. What about the Statistical significance achieved in the well controlled double blinded clinical trial? Inadequate numbers means we failed our endpoints, this is not the case, we passed them with flying colours despite n being so low. What do you think will happen when the same trial is conducted with an increased n from 15 to some 195?
TheLeakyShip is sinkingQuite the contrary, it is my distinct prognosis that this ship is not only going to set sail..it's going to fly.
Send me those references.
Ref:
1) https://onlinelibrary.wiley.com/doi/10.1155/2018/9524075#:~:text=Histamine%20is%20a%20potent%20inflammatory,and%20possessing%20high%20chemoattractant%20activity.
2) https://www.oarsijournal.com/article/S1063-4584(06)00160-9/pdf
3)
https://ipsearch.ipaustralia.gov.au/patents/2021201198