Yes indeed a legitimate question.
Now I'm not privy to what the question specifically is and how they are answering it...so I'm only going to talk generally about it and just scratch the surface if you will.
Yes it is just one question, but we don't know the detail...we understand it's got to do with some observation in an organ of some description pre clinically....and we also have clues from the Investor forum that we had that it is centering on the mitigation aspects, a building in perhaps into our upcoming (fingers are crossed) 3rd phase trial.
What does this involve...probably more than you and I are going to personally see.
They not only have to come up with a suitable test...think bio marker or some sort of other indicator, but they have to document and show how this will help to monitor for the possibility of this observation. They must incorporate this protocol into the current trial design, they must factor in all aspects of this new test, how will they test for it, what will they do if the test reveals something...how will they report the findings or lack thereof, what is the escalation process, how does it affect any other part of the trial design. What other areas will this test and observation overlap with. eg Will it affect Tox...will it affect future recruitment...who is responsible, can it go along with the current lab reports?
*Takes breath*
How does the test and the result impact by race, by gender, are there any differences that need to be considered for this new monitoring. Is there an impact of new monitoring on old? Can the results be connected, or they independant? What are the ramifications of certain grades of observation if they happen....Are there any false positives...who can garner these results, does it need to be audited? What paperwork is required, are there consent issues, can it simply and easily be built in to the current trial design? What is the flow chart if in the unlikely event (completely my views) that we observe a fraction of what was observed in the preclinical model?
Go deeper than just the surface...thorough well planned and well thought out answer to the remaining question at this most critical stage, is most important.These are just a few questions that need to be answered and designed for and I haven't even gone through the FDA site...I'm sure there are a few more questions that I'm forgetting about totally.
Now all of the above is enough workload, they then need to check and consult that they themselves haven't forgotten any aspect so thats meetings with their experts in the USA, getting time, having meetings, checking and then drafting. Once thats done it all needs to get checked and approved. I reckon my editor here on HC is ok (
err... thats just me), it takes me literally hours to put some of these bigger posts together and STILL errors slip through and the autocorrect does some whacky-like things. Team PAR cannot afford ANY errors, not even typos, they would be frowned upon. Yes they will have external publishers to help to put it together, but not unlike someone like an agent filling your tax form, the onus is finally on the person that signs.
Do we want a rush job?
NoDo we want something that is just checked once?
NoDo we want just
one clinical and
one non clinical expert to check our work and give their opinion?
NoDo we want most if not the entire PAR team to go through with a darned sharp electron microscope and test and recheck a few times?
YesDo we want to dare try for another iteration, another loop of the flowchart...another pass at the bouncer if we can at all avoid it?
I don't think so!This takes time, even for a 'simple' one question.
If they need more time, take it...just gives us the highest percentage chance of answering it fully and completely.
Just my views
(20min delay)