On the "Hope for the Best and Plan for the Worst" front, I am most concerned that the Human Factors Study will be less than fully successful and the FDA will require an additional HF Study that involves more active training of the first-time user.
I say this because:
Ed Cox told me years ago that certain phase 3 senior citizen subjects with certain pre-existing conditions needed help applying Vitaros correctly. It is certainly not a quick and easy application -- for example, the directions say that an overfill is common and a large quantity of the cream commonly spills over the penis (to be rubbed in).
The company says that the E.U. doctor explains the instructions for first-time use but is not required to observe and coach the patient through first-time use. I got the strong impression that the company is happy with that "training" model regarding the upcoming HF Study.
So, without any first-time application involving a professional to provide coaching in real time, there is a real risk that at least certain subjects in the HR Study may not get it right.
I am wondering if health care provider-assistance is required during first-time use of Muse. If that is the case, then the FDA might -- or might not -- end up requiring that for Vitaros as well. Right now, the company believes that verbal explanation of the instructions is all that is necessary to train the patient.
Does anybody know about whether Muse patients fend for themselves during first-time use? I would imagine that professional assistance is required, but I don't know that for a fact.
