I enjoyed your summary, it was a good read. We certainly are at a cross road here. There are a few pathways this can take in terms of funding.
The greatest thing for me currently is the upcoming acceptance by the FDA of 012 in terms of how pivotal this will be in finally getting us to fund the P3 itself. Yes we have really good and valuable guidance now, it's a question of implementing this and paying some diligence to whatever the comments and suggestions are.
Yes I too have found PAR somewhat lacking in some areas as well all know in the past and I do believe some of them have been addressed but more work is needed, sorely. However, one thing I cannot at all fault is their acute attention to detail and comprehensive rigour to the clinical programs, from the design to the analysis and execution of recommendations from all parties, consultants and KOLs through to the authority themselves.
Once that is accepted, funding and subsequent commercial transactions will have a much higher chance of materialising, in my view.
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