After a given study it takes a few months to analyse and then to...

After a given study it takes a few months to analyse and then to read out.

In this case we don't just have one study.

Your '10,000 plus' pages could even be conservative!

I agree with you Denial, there is a lot to digest:

1) TYPE D questions

2) Proposed Trial Protocol dosing 2x2 acceptance as MED.

3) Phase 2 clinical data, some 600 patients here in our stage 1.

Add to the above 5 separate non clinical data studies.


This is a lot of data.


Now the above is a lot of work for many different departments...I'm not making excuses up for the agency or for anyone else. Im just saying that maybe this is also why this thing is taking it's own sweet time.

Its frustrating waiting every single day, but the chance of getting this right is divine. If this thing works out, cant tell you how much it will mean.



But I have forgotten one more thing that might also add some time.

We have totally added and changed the protocol.

We are REDUCING n by 17%. Not increasing, not adding some competitor arm, not holding the number. (New guys - there is no competitor arm...there is no current SubQ systemic route of admin).



We have added a whole new timepoint, 12 months. We didn't do that for fun, to add cost and time...we did that because of duration. Show that to a partner and they are going to love it. Actually they are going to freak out, to have a great drug that's safe that works BUT to have the duration of effect longer than a month or 6...they are going to pay for that.


And if what I heard from Paul is correct, we are even adding some DM type observables via MRI. The Quant data will be highly highly sought after by anyone that's even remotely interested in our drug. It was grand in 008, it will trump in a P3.


This is not a joke. It's a material change. It will take some effort to pass it and approve it.

I agree with Torpy who suggested there were some 4 sets of eyes on the prospect we are close. Its not just one euphoric guy saying it. Yes we are being led to believe it's soon. It becomes a little relative after we have waited for 6 months...


I'm not going to come up with a corny sayings like good things can happen for those that wait. It's been a long slog. Its not nice taking phone calls with ppl asking why isn't this thing going up if it is so good. I feel for Simon. But I also look at other plays I've been involved with and it's been a long time for them to get off the ground too. The rewards have been staggering IF it works out.




DYOR