Isotechnika Pharma Inc IPHAF

Dysfunctional Advisory Committee

[Plato5]

These advisory committees are just that - advisory. As the PR announcing the now-canceled meeting states: "The FDA is not bound by the Advisory Committee's recommendation, but may take its advice into consideration when evaluating the NDA for voclosporin." My sense is that one or two players on the committee - for reasons we may never know - raised questions that could not be resolved with the given data. The FDA is continuing its review and may or may not consider those questions material. If ISA/LUX has followed the procedure laid out by FDA to the letter - and I believe they have - these unresolved questions could well be red-herrings. I am imagining that the committee chair - realizing that the committee was effectively becoming dysfunctional - because of these questions - decided to cancel the meeting. I've been on many committees in various capacities over the years and my experience is that most committees have members who can easily derail a process - if unanimity or consensus is required - which I believe was required here.  Rather than muddy the waters, the committee chair simply canceled the meeting. The FDA will be aware of the questions raised by isolated committee members - but never discussed in a meeting - and will be able to address those questions before Aug 3 - or simply state that the questions are immaterial. It is also probable that the questions arose from members who had not properly reviewed the data. It is also possible - given the incestuous nature of this business - that the questions arose from a member or members of the committee who had a vested interest in bringing red herring objections to the process. That is not at all unheard of and something I have seen in committee work. The committee is a good idea, but unlike the FDA internal process, the committee - or members of the committee - may have ulterior motives - political, economic, or otherwise - to see this application fail.