Ann: PAR RECEIVES POSITIVE RESPONSE FROM US FDA FOR PHASE 3, page-130

Yes it does seem there is a bit 'open' in that ann. without it explicitly mentioning acceptance of n as others have stated.

I believe PAR will address the details at some upcoming point, perhaps when the final IND is set?

It's a big relief that 2x2 is done, this was a major hurdle, yes a number of us prob thought that it is more of a given, but until you get it in writing (and what a wait it was!)...well you just don't know how it can play out


Monitoring, yes well there in my mind was always going to be some. I thought that if the FDA made us do it with dosing LESS than 2x2, there was always a material chance we would have to do it if the dosing was MORE. (eg 2x2). However, I am also led to believe that it's not a linear relationship. Ie this adrenal finding at a given smaller dose does not necessarily pertain to higher chances at higher dose etc. Anyway the FDA will be conservative. I also feel that PAR would have budgeted this screening and monitoring in.


Timing for IND? Well there will be some time required to compile and go through the feedback. I would guess it to be 2 or 3 weeks, maybe a fraction more? Then the next step once it is formally filed is to wait 30 days, that's statutory so the FDA must get back to us within this time. I am very happy that PAR sought out guidance, though it took forever and a day...it means that IF Par follow the guidelines/feedback and there are no surprises, the 30 days should be the end of it and we have our new 012 open. I don't want to even entertain the thought of what might have happened IF PAR filed for a revised IND utilising the normal pathway, ie we could've cycled for 30 days many times and thus had more time waiting than we have already had!!

From here? We need to address funding.


Funding, again personal opinions but this green light is a big one and I believe genuinely it will fire up some parties. How does this translate, when does this translate, we will have to see ! It also doesn't mean we have to wait until we get our IND (012) open, ie funding could strike earlier or at least the conversations could progress during this time. I personally very much doubt we will do a dilutive CR, but it's not impossible, I admit.


Yes I had a number of calls asking why the heck is the SP not moving up if that was such a good Ann? It boils down to funding for sure, this is what we now need, this is now the next biggest question mark.

Don't forget, there can be fun surprises on the way for us now that we are thru the first barrier/hurdle. TGA could strike anytime too...it's not guaranteed but there is a material improvement of chances of this now.

Don't forget, for those that are new or don't know, TGA provisional steps:

Step 1 Determine if we are eligible for us to apply (on going, this should resolve fairly soon, maybe a week or two??)

Step 2 If 1) above is YES, we then submit, prob would take a month or two at least to compile all req'd data/info.

Step 3 Wait about 6 months

Step 4 IF granted, we get a provisional license, first sales in Aus. but also a distributional deal in Aus would most likely be forthcoming.
iPPS would not be covered by (PBS insurance, but we'd have sales here until a full licence granted (ie by USA/Europe).






Onwards and upwards, it was a good day irrespective of the disconnected SP.





DYOR