Mainly comprising of my own opinions and thoughts but my read...

Mainly comprising of my own opinions and thoughts but my read was this:

Normally they would've waited for a response to their Type D (that was initiated back in Jan), then they probably would've worked on an IND and then submitted. This would have the advantage of getting back a response to the Type D sooner and then they would file for the revised IND.

The distinct disadvantage of doing it that way would've been we would be subject to a crazy 30 day cycle over and over as each question is asked and answered. Yes FT would help, but not by too much. We went through that ugly process last time a few years ago when we filed the original IND. 7 cycles was crazy frustrating.


INSTEAD they did the smarter thing of simultaneously putting through a DRAFT and requesting feedback on it. This saved them time (thought it took an inordinate 5 months or so to get feedback), now it's a relatively simpler case of going through the detailed comments, implementing and then submitting the final revised IND. This will have the advantage, on the proviso that they implement the certain specific comments that are a bit more than just general feedback, of putting in the final revised IND and there really shouldn't be another 30 day cycle after the first one. In other words we should be able to sail through getting the IND back within just ONE 30 day cycle?

Now in my mind this putting through of the revised IND (for 012) will still take about 3 weeks from now...there is a stack to do. There are detailed comments on no doubt multiple sections. In fact the more I reflect on it, I don't know if they can do it in three weeks time, there is a lot to do, any revisions involving stats is a very careful process they need to do properly. You do not want to take a chance in under powering a trial! I could look up some stats for you guys but a LOT of trials fail because of under power or poor design. Yes we have the bulk of that out of the way, but any tinkering and you must, simply must, implement this carefully. If it takes an extra week or two, well we have to grin and bear it.


Im hearing the FDA have been supportive and have actually come up with some good and interesting suggestions that PAR need to consider. I keep thinking of the interview with the Clinical expert that we did a number of years ago here at HC and this guy that we interviewed that has had a stack of experience in dealing with the FDA said at the time that the FDA are actually on our side. They want a good drug to get through.

I've reflected a number of times on this statement, it makes sense. How? Because they too will get accolades ONCE we get to market. To have a safe drug out there that's novel and is SO SO SO broad acting that it will affect the lives positively of not a few hundred but a few million potentially...well that's awesome and they will share in the rewards of real patient benefits. It'll prob also go some way in reversing the progressive damage of Opioids out there.



In answer to your good post newinvestr0r, I would think that PAR were at the mercy of the FDA and that the response time was way over what was the norm. Yes there was a massive stack of data that was submitted by PAR...but despite this, it was at least a couple of full months longer than what anyone was expecting.

Par will now consult with the respective KOL's and implement the comments to a T. I know Paul is great at doing this. Yes we can get better at a number of areas and we need improvement, I know what a lot of you are complaining about, but one area you cannot deny is the sterling job they do from a Reg and a Clinical point of view.




My views.