Hmm good challenge for me..Yellow Stoplight-wise for TGA eh'?
Ok I'm going to assume FDA get back to us (Type C) by early Jan (2nd week)...why the slight change from my above post which wasn't posted all that long ago? Because Covid is ramping up there in the USA..so I'm adding some time to be a touch conservative....let's now add 2 full months for them to submit....and then add 202 working days (9.5 months)...that gives me the last few days of the year...dang...everything slows down and shuts around Christmas and New Years so I'm now saying start of week 2 Jan 2022.
I'm really hoping there are a few shades of green there and it's at least a month earlier (ie mid Dec 2021) but that is totally subject to how long it takes TGA to give us the go ahead which can vary a bit...what will help us is:
1) The total lack of Covid cases here in Australia, this will not hinder the assessment for provisional if Covid is at bay here.
2) The strong evidence we have amassed so far and the great rapport we have established via the SAS with the TGA already.
3) Any positive feedback and general smooth sailing the FDA provides between now and submission time, which has a higher chance of happening based on how the EAP program has gone, the excellent Pre IND meeting and the ongoing constructive and correct and highly professional team and attitude PAR has shown in terms of respecting what the FDA are saying to PAR and acting accordingly.
9th of Jan 2022 is realistic Amber light forecast from me but hopefully it will 17th Dec 2021.Chance of this happening?
High...what would put a spanner in the works...really only the advent of a number (not just one) AE from a patient during the P3 trial. It would have to be quite serious and not just one patient I would have thought as the sheer efficacy and the top class results in terms of pain reduction is simply unseen...unheard of...no there IS NO DRUG IN THE WORLD SO FAR that had done what we do in terms of pain and positive workings and results on OA. Simple.
Based on what I have seen...
I can't see the percentage chance of success being any lower than 98%.Sorry I couldn't just answer your question in one sentence, had to give you my rationale.
FROM MOZZ's Legal team:
I am biased...
It is my own opinions
What happens could be totally and completely different to what I think/forecast
This is a rough only
Do NOT rely on any of the above
DYOR
(20min delay)