research reports and media, page-4390

StrangeLogic:

Im sure I could write a thesis on this one....




CONS

Yeah it's really a program to ensure the best critically needed drugs get to market quickly!
While there are only a tiny handful of drugs that are not oncology, virology and indeed haematology, there still could be scope for a drug like ours to get through such a program.

It will take it's own time for sure... if we are deemed to be eligible
Yes you could be also right, they may not see it in the same way as those other more 'immediately fatal' indications.

How much will they take into consideration our broad based mechanisms?


PROS

We could genuinely get revenue quicker than the slow, cumbersome FDA Phase 3 program. That really will take some time as we have a number of patients to dose AND we have to sorta of wait a year for the durational aspect (12 month time point) and then final analysis and then read out.

It will be the ultimate proving ground though. First time revenue, profiling a great drug in a localised market for us. The data, the forecasting, the models, the challenges, logistics, timing, pricing, delivery, feedback, all will be nice and easy to analyse before we hit the really huge world markets.

It's sometimes hard for me to see how they couldn't accept us (but I might be biased) (somewhat), Better pain reduction, function improvement, duration, safety. less reliance on other nasties...you get the drift.



In answer to your post, my thoughts are that while I agree with you that it may not result in direct funding...I also kinda disagree. Imagine there is a partner sitting on the fence, waiting like us for the Green light. We not only get a green light from the FDA but we get one in addition from the TGA.

It will be the ultimate prize and will automatically flag that yes, we really do have a supremely worthy drug that made it through determination that's NOT directly addressing cancer ! It will be the biggest validation that they are funding a company that has the right to a drug that is a total game changer (my views).

It will mean that we have a drug that is treating a serious, unmet condition but also that there is a major therapeutic advance along with a favourable comparable against what is out there in the market.

It is already Fast Tracked in the USA, but now we have this additional quicker pathway. The value for us will definitely go UP! This could be a major pivot that helps them get off that fence and over the line in terms of seriously thinking about funding us. It will also require a funding/distributional party to start moving, we could genuinely only be a year away from revenue start.


I dunno about the whimsical share market, I do suspect that behind the scenes this will create quite a stir, in a good way


Personal opinions