Not sure what the panic is about. Unless I'm missing something.
My thoughts:
- FDA seems to be unconvinced surrounding the perceived risks of that have surfaced, or at least made headlines, this year. This is the most serious and existential topic for Axiron and the news appears to be positive.
- TRT does restore testosterone back to acceptable levels in patients that have hypogonadism. It has a role to play here. FDA has approved it. There's no debate to be had.
- The controversy surrounds prescribing TRT for men that have low levels not caused by illness but rather as a result of "old age". Not really a disease per se but more of a quality of life argument.
A cursory glance through the briefing pack suggests the FDA is concerned around the advertising of TRT as a fix for this. It's never been clinically proven and it's not what TRT was approved for. It sounds like "off-label" use; which is perfectly legal for doctors to prescribe. However, drug companies aren't supposed to advertise it. Worst case is that they have to tone down the advertising whilst studies are pending. In the meantime doctors can still prescribe for any use they see as being safe and effective, even for patients' vanity and cosmetic reasons.
- Unrelated to the above but there's a new CEO coming on board in November. Assuming he's worth his salt and done his due diligence, why would he leave Europe where the action is, join a company HQ'd in Australia that has 1 product that shrouded in controversy??? Perhaps they are saving up positive announcements for when he joins...
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