Isotechnika Pharma Inc IPHAF

another angle on action letter

[teevee]

There is another angle on the FDA action letter not yet mentioned:
Sometimes regulators, for reasons they prefer not to elucidate verbally or in writing, will use policy to achieve their aim. The result being that applications end up on the bottom of the pile, and when eventually reviewed, "action letters" and other tactics are used to delay until the applicant "goes away" or the application becomes stale dated.  Considering the material impact, I hope and expect the FDA action letter will be disclosed to the market on a timely basis.