And that no one knows...how much will FDA want?What further...

And that no one knows...how much will FDA want?
What further questions will they have?
Do they need anything more?

It could really be days...it could be weeks, I hope it ain't months!

The law of probability states it's going to be some time...

Why? Cos there is just so much data that is new since our last IND.

Now a few will take that as a negative...my glass looks to be a little more than half full...so I take it as a positive. It's good that we are giving them new data and its not just any old data, those 008 announcements were crazy good and that's what WE know...what do we not know?

Oh there is so much we don't know.

Can you just take a moment and imagine how many data points there are?

There are something like 6 biomarkers that PAR reported on....each patient was checked before, during and after...these are the markers that we know, there could be more?

Apply the same for MRIs and structural observations.

Within MRI's *takes breath* there is BML, size, grade, volume, morphology

There are Osteophytes

There is the usual WOMAC measures for Pain and Function and perhaps stiffness too...for each and every patient.

The above is a lot, there is more


PGIC...

Patient questionnaires/surveys
Rescue Medication.

Im sure I have missed a few....this is going to take a while to compile and then submit....PAR, make sure you check it all ...!

Then the FDA get receipt of it and have to disseminate it.

This isn't a week's worth of work, they will break it down into all the departments and each section head will go through it and divvy it up...they will have meetings about it and see if they have any further questions.

This isn't going to be a niche drug that only 0.000003 % of the population use.

This drug could actually be used by a few patients in the future yeah?

Safety! I knew I missed one....Tox....Pharmacokinetics!


And you know what else I have forgotten *Takes another breath*

Revised protocol. We aren't just shoving wads of data over the FDA table...we are also forming a revised plan...this entails a lot of work.


I'm no Buddhist that can sit and mediated for YEARS...I too want a darned quick result, PAR, don't you know I've been waiting since IPO?




_{Not me!}


But, I would rather them take their time and get it right...coz if they get it right and we get green lighted eventually...it will be big....SO big that I personally can't see how we wouldn't get funding from somewhere to continue on with the POSSIBLY greatest drug in known history.




Big statement, DYOR...


- Mozz





ps: Now you tell me what the timeframe is going to be like? I hope soon...but Im being as patient as I can be.