PAR. SP, page-1119

Rightio, now that the heavens have opened up a fraction (!) ...what's to come?

Well who really knows....I've over simplified it with the following diagram, I know there will be a small number of you that are wondering what are we all expecting...







So we have the FDA feedback which is hopefully very, very soon....they will essentially give us feedback on the questions that were asked earlier this year, the most pertinent of them being, is 2 x 2 dosing all good to be used from here on in? Ie in our P3.

Also, at the same time we should hear back about any commentaries the FDA have on our draft P3 which will incorporate a number of changes that Paul has alluded to just recently. Changes such as n and additional observations along with a 12 month look thru.

Now the above diagram is a very simplified version of the possibilities, there could be many more that can take place so certainly don't rely on it !
It's really just a simple illustration for those that are wondering.,

I believe the FDA feedback will indeed be first and now I cannot help but to think that the TGA Determination must be somewhat linked to the FDA decision and PAR being able to formally submit the IND application for the Phase 3. This also will include the determination of the dosing to be used in the TGA application if we are determined to be eligible..

So that gives us four very high level outcomes. The little Green arrow is the most desirable. The Red arrow would be the least.

I would suggest that the TGA determination decision would come some time after the FDA feedback but who knows, they may not get back to us until the FDA IND is formally accepted?

I would think once we get the (FDA) feedback it might take a few days to sort it. Depending on what is said, will depend on how much time we need to tinker with it and then the formal application would be submitted... then it's a statutory 30 calendar days for the FDA to get back to us.

Then we are allowed to start.


The TGA determination would be also very good to get in addition, but we will have to see, we have a strong case if you follow the legislation.




All above only speculative personal opinions.
The actual number of outcomes could be many, many more, the timing could be totally different.




DYOR