Hi Bobsee,Thanks for feedback.Quite a difficult question as...

Hi Bobsee,

Thanks for feedback.

Quite a difficult question as there are many moving parts, there could be hurdles and delays, we really don't know.

However, can have a rough stab...note that the below can vary, by a lot!

So let's assume it takes 2 or so months to finally get a green light. It would be a great result if we do get it by then...it kinda assumes there won't be too many questions and if there are a few questions we can get answers back to them pronto. Remember though, there is at least a small chance of the Authority asking us for a little additional data or a question that takes a bit longer to answer...there is at least some risk of further delay. I hope it doesn't pan out like that...we are FT so that helps but it's not impossible that something takes longer than we all like.


That's July sometime if it's fairly smooth waters...

Par would then have to finalise funding if they haven't already. It would prob be a couple of weeks at least before they are ready to enrol and dose.
How long is the clinical program? Well I'm guessing it would be around a year...but even that's more complex because you don't start dosing the entire group in the first week. You ramp up, but that would easily take a couple of months if not a fraction more. What is n? Have they built some fat into n, they would for sure to count for drop outs etc....but a bigger n isn't necessarily a bad thing, it's a little overpowered and hopefully an interim readout will depict a better result. If its a bigger number it will take longer...what is monitoring? If it's onerous then that too takes longer. So that one year rough timetable is not from first patient dosed...its really from LAST patient dosed.

Within this complexity is the interim read out and how the data comes back...the good thing is that we should have rolling batches so we don't have to wait till the very end to submit the data...if the data is stunning then there are faster pathways potentially...it's a question then of stats. The stats governs a lot.

At the end of the trial you need at least 2 months to compile all the data and then have a read out. Then things get exciting (if they aren't already exciting by that stage) and you need some time for Marketing and Labelling, usually 10 m, I reckon in our case it won't be more than 6, hopefully less??

Get a material dela in here somewhere and we will all hopefully be adequately distracted with how the SP is reacting...



So look, you can take a very optimistic viewpoint, you could be somewhat realistic or you could be pessimistic.

I reckon we should have in our minds something fairly conservative.

If I were pressed I'd say possible real P3 start by call it Sept/Oct...prob more Oct. I hope it isn't later than that.

Conclusion of overall trial by end of 2025??

I must say that there are chances for an earlier readout at least top line or interim...but I try and not necessarily count on that. IF it happens and IF the data is spectacular...well...maybe it might be time to buy some of those gold party balloons early in advance.

We have seen things take longer than initially thought of in the last x years...yes I think we have one of the world's best, efficacious and SAFE drugs...this does not mean we are getting the red carpet treatment at each and every twist and turn...it means we have a better chance of success, but no way is it 100% so might be prudent to think more on the conservative side too. In fact one could make some argument that BECAUSE we have such a good drug and the possible indications we could apply it to are numerous, the authorities are going to look deeper not more superficially at us?

Once we finally get that green light, well just lets see how we ace the test...I think we will ace the test (spec statement).



Not raining on any parades...just trying to build some decent conservative fat in this business end of the clinical trial program. I'd rather set my mind to its going to take longer and be pleasantly surprised.



Completely my thoughts, very hard to know exactly how long things will take, can only come up with roughies at this stage in terms of possible timelines!