So let's quickly re-cap....We are patiently waiting for the FDA...

So let's quickly re-cap....

We are patiently waiting for the FDA to get back to us to confirm the P3 protocol.

Once that is set then we get busy and finalise it and submit. They check, approve and sanction...


We then have a green light for what?

A Phase three.

Not just any Phase three...but for a drug that has the efficacy of Tanezumab (11 plus years ago)..that attained $1.8 BILLION not Aussie $ but USD.

This for a drug that showed Rapid Progression of Joint Failure...it was enough to immediately stop their progress.

Even as recent as last year there are articles being written like a post mortem on the drug...take a look at the below headline:







So acutely a solution is required for a decent safe pain reliever!

Let's take a quick look at the results they obtained in the pain endpoint:

At week 8, the proportion of patients with at least a 50% improvement in average pain was 12.3% in the placebo arm and 25.4% in the tanezumab arm (P=.0405).¹

How do we compare?



55% of participants receiving iPPS twice weekly reported >50% improvement in pain
compared to 28% in the placebo arm. ²



We more than doubled the numbers...and that was a measure not at 8 weeks.....it was at 12 months!!!!


p values? Check it out for yourself:



But the above wasn't on n in thousands...it was 15.

Not 15 thousand....


15


Mate.

But Tanezumab caused pathological fractures is about 2.8% in the active arm and was zero in the placebo cohort. It was discontinued.
It may have shows efficacy in terms of cancer pain...but it didn't matter.

A few points on the above in my humble

1) We reduce pain better than than Tanezumab, and its going to be all about the Primary ie PAIN...the off label usage I envisage will be somewhat prolific. So much so that I believe we just can't imagine the future sales potential of this. A good pal of mine has no hesitation in reminding me (4 times in the last 2 weeks) about our low SP compared to the gross mass potential of our future value, our future NPV....


2) Look at that deal size some 11 years ago...this is our potential (plus inflation! ...and safety profile)...but ..BUT....Tanezumab was never shown to have any DM connotations.


3) Tanezumab route to admin. is more onerous than iPPS..it's intraarticular.




Ok so getting back to my original point....we then, if all goes well, get a GREEN light for the P3....after al these years....after all the data...the amazing programs that has gotten us to this point...for a trial that will finally show the world what indeed iPPS is capable of (I haven't even really covered a fraction of it on the last 4 years, not being flippant..I'm being honest).


Once we start, it will be rapid, we have 65 sites ready to roll. We have Crossovers ready to go....we have Alumni ex-pro footballers with their previously seen high results (n only 10 though) recruits in the wings....


We aren't talking tens of thousands of patients (Tanezumab was building up to 6 studies with some 7000 patient by the way³ ).

The trial would go for 28 weeks (not for two or three years!) and we are done...maybe some read out time...some marketing and labelling...



@Friendsandco Ive been more than semi excited for 5.5 years now...the candle still burns brightly...the real excitement is to come






Of course my personal views.


DYOR








REFS

1) https://www.oncologynurseadvisor.com/home/cancer-types/general-oncology/tanezumab-cancerp-ain-no-longer-development/#:~:text=The%20researchers%20noted%20that%20the,the%20treatment%20of%20osteoarthritis%20pain.

2) https://app.sharelinktechnologies.com/announcement/asx/76393c2170325bd8cd425f9c4d0ffaae3) https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_lilly_announce_positive_top_line_results_from_phase_3_trial_of_tanezumab_for_the_treatment_of_osteoarthritis_oa_pain