Going back to 2mg/kg twice weekly is a big win for holders in my book. That has given me peace of mind regarding trials. 1.5mg/kg twice weekly would have been ok too, i'm sure. That was the word out of PAR a few months back - but the original dose means the trials are a cakewalk.
That bloomin' rat, hey? All this trouble because of that adrenal issue reported in one rat, in one study out of hundreds, thousands over the years. This drug has been used in millions of humans and animals, and never a serious adverse event reported - but then this one rat! Fair enough. Safety is paramount, and the FDA couldn't just overlook it. Because of that issue, two major things happened to our Phase III trials. Firstly, PAR added testing to their trials, to monitor for any such adrenal system issues in trial participants, and secondly the FDA said 'hey, try to find if there is a lower effective dosage to mitigate this risk'. So, we ended up with the dosing study. 2mg/kg twice weekly has been the perfect dosage for years. Hundreds of lives improved, knees saved, pain avoided, function regained, health restored via SAS and trials. Now the FDA wanted to try a few experimental doses, just for shits and giggles. PAR, wisely, didn't make a fuss and go against their wishes. Sure thing, let's test them out. Now, safety was of course fine, as it always has been. However, the risk was always going to be efficacy.....and especially efficacy across the longer timeframes such as 1 year. This study has shown us, that 2mg/kg twice weekly is the dosage that will provide a years worth of pain and function mediation for patients. We are confident in it's safety record. According to Donna we have mitigated all of the FDA's possible concerns, and the message today was loud and clear - we are going with the dose we know.
This is, at the end of the day, PARs decision to make. And it's PARs risk to take if it doesn't meet safety criteria.....but frankly, we all know it will. Kudos to PAR for not defying the FDA, which we know doesn't tend to go over very well. They worked with them, they ran the experimental dosages through clinical trials, and they got the data they needed to inform their choice. I for one, am so glad to have the certainty of that dose. To me, Phase III with this dosage is an open goal.
What a graphic this is to show what we own. There has never been anything like this available to sufferers. This is just a matter now of riding whatever the market can throw at us to still be in the game when this stuff gets to market. It has the potential to make more waves globally than Viagra when it hits pharmacy shelves. Want a piece of it? Hold fast. The next year or two are going to be wild.
TGA provisional approval application is also a great piece of news coming out of this announcement. Possible sales, possibly even with PAR pocketing the entire margin for Australia sales (love that confidence) my mid 2025. Added to further information on OA partnerships, and clear confidence in an MPS deal, this was all music to the ears of long-termers. There's so much more to unpack, and we still haven't been treated to the 12-month MRI results.
Looks, the market can do what it wants with the SP for all I care. I'm not selling a single share until this has played out to the end of Phase III trials. It can be at 10c per share at that point, and i'll still be holding/adding to see those results - because what comes after will be even more wild. Mr Market, you'll get these shares from my cold dead hands.
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