I was going to let this go, but worth responding to with how I see it. My response in the purplish kinda colour...
The science is in question.
Mate, you are a smart cookie, you have been following us for so long, how is your memory so selective? What science from any other competitor is even in the next door's car lot of the ballpark that we are playing in?? At this point, what is there that comes remotely close to what PPS is displaying? A question right back to you - WHO is questioning the science??
A 30,000 page IND that took months and months to get through with caveats by the FDA.
Yeah and you think this will take what, a month or two to get processed during the height of Covid? We were lucky to get it through in the time we did. At every step the FDA made us wait for the full 30 day cycle. How is this Paul's fault? You would be happy if Paul and team argued and disagreed all the time and refused to do any other studies in the background and then quickly proceed with the basic and not have any 008 data, not have any retreatment data, not have any safety set or work with KOL's though they were expensive in terms of time burn and cash burn? Caveats from the FDA? You mean like we can only ever use the bene formulation?
2 years of PAR doing non-clinical studies in the background and a failed dosing study results in very very lukewarm reception by the FDA.
The 'failed' dosing study was at the insistence of the FDA to find the MED (Minimal Effective Dose). We achieved this, it's 2x2. We also have significantly added to the safety profile of the drug utilising Stage 1 data. Lukewarm is not, as Babba also reminded you, a case for Fast Track. Please list for us the number of companies from Australia in the last 10 years that have achieved a FT designation?
How do you know the reception has been Lukewarm? Fascinating. I think behind the scenes they are amazed and are wanting more time to go through this amazing set of data? (my views only).
TGA provisional approval gate should have been by now - so why the radio silence. The timeframe should be 30 days from submission at this checkpoint - a submission they delayed for four years.
After talking to TGA, PAR needed to display a drug that is much beyond the therapeutic standard out there. Claiming merely Pain and Function improvement is not itself a material improvement. We needed something more than just pain and function. We achieved this finally late last year. It takes time to put that together and submit. Are you realy crying over it being a few days late? You do know that it's a one and done, if you attempt to do this and ignore the guidance the TGA gave us and got rejected, there is no going back for this application.
We have had a few deadlines that have been missed before, this happens. Maybe some of them are PAR's fault, I'm guessing a lot are to do with authorities or just how things can change along the way (remember 008 changing massively half way thu). Most again have been to our advantage. But I also understand this is hugely frustrating if we are solely relying on strict deadlines and if we want this to be a quick return. If this frustrates you, well maybe just maybe it's not for you.
Why do you assume it is the sky falling if it's late, our IND last time took 7 months, there was a lot of angst...a lot of worry...a lot of doubt...at the end of the day it got approved, we progressed. Same thing happened for Peer review of RRV...that took a full year longer than we thought, I distinctly remember a few comments here saying iPPS doesn't not work for RRV, this is why we aren't getting Peer Review. The data set produced was unheard of, it knocked it out of the park. Faster regression of the alphavirus arthritis!! For those that even bothered with it realised that CTXII was quoted...the single most prognostic of all OA biomarkers, what credit did we give to PAR then and even now.
Nothing.
There was barely a clap or acknowledgment.
Let me say, I know some investors that do give that credit. They are few and far between. These few know how these are the breadcrumbs...They know what may come one day for us. (spec personal statement).
...and if you think that’s bad - a fund management firm that has no experience in pharma is now hired as their business development consultant to get them out of this mess.
Right so when we don't have help we cry...when we get someone with expertise in deal making and non dilutive options in funding, we want better? Who better to get than someone that has real skin in the game, has a supreme track record of super deals and understands the market so well? Who better to get than someone that knows management inside and out and has been across our story since before IPO? Let me tell you, we don't want someone that has a resume full of super deals but cant work with our management, that don't know the product inside and out and worst of all don't get what the hell we will actually be worth in ten years.
Right at this point of time I only want someone that knows our actual potential...that knows the science that only WE are displaying, multimodal...but symptomatically and structurally and how the heck this thing is working.
I'm trying to make sure the small investor/uninformed knows the facts.
I'm also not saying everything has gone perfectly and if we knew how this would play out we wouldn't have done some things differently.
(20min delay)