Likewise, my knowledge of the post-trial registration process is scant. I would hope that Fast-Track designation and access to the best minds around on the topic throughout the trial process will somewhat mitigate the chance of nasty surprises (i.e. new data required) post-trial - but only time will tell. "Expect delays" is probably prudent advice regardless.
You're right also that there are grey areas around DMOAD. The FDA have put some language together, as they have for Accelerated Approval, but they can't define with absolute clarity for OA because there are still substantial knowledge gaps. One of the telling remarks from Virginia Kraus' presentation to the AF/FDA forum was when she admitted that the OA/OA Biomarker/Regulatory landscape is awaiting the existence of a DMOAD before they ultimately can say with certaintly what it is is that modifies the disease! It was sobering for me to hear that - because you assume it would happen the other way around. i.e. You think there would be criteria set out to define what a disease-modifier needs to do to be classed as a disease-modifier - when in fact, the science isn't there to do that yet. They first need to witness a therapeutic which conclusively modifies the disease, then explore the mechanisms of action which have led to it (or in the case of AA, are "reasonably likely" to have led to it). Staggering to think there is still so much unknown about a disease which impacts so many people.
Can't fault your last paragraph when I think about it. "Expect problems" is as prudent for the PAR board as "Expect delays" is for us shareholders. However, it is difficult to imagine how we can be in a better position at this stage of everything. With trials, the historic results are so very encouraging. With registration, we have that Fast-Track designation which gives us invaluable access to the Agency throughout the process. With DMOAD, we will soon have the 6-month PARA_008 data in hand which Donna says we will take to the Agencies, to try to roadmap what they need to see to determine the possibility of Zilosul being accepted for Accelerated Approval, and ultimately the first OA disease-modifier. There are no guarantees, and it's good to remain mindful that all sorts of things can still go wrong (especially, as you point out, if you're a PAR decision-maker), but gee plenty to keep us optimistic too.
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