FDA questions efficacy of testosterone and whether risks really do exist, page-12

Hi Value,

At a very simple simple level, caused in no small part by the fact that i am a finance guy, Axiron is a treatment for hypogonadism. Those who are prescribed Axiron are likely to have primary conditions (other than ageing) that caused their low testosterone in the first instance. In their initial concerns raised in January, the FDA were keen that adequate health warnings were prominently displayed on the packaging and GP's were aware that there maybe some side effects to taking Axiron. In the research, there doesn't seem to be much evidence of there being adverse consequences to taking Axiron as a HRT, but there is no available data on how many takers of Axiron are doing so due to hypogonadism.
Here the plot thickens, as there are people taking Axiron who may not be suffering hypogonadism, but are nonetheless taking Axiron, more as an elixir. The FDA also wants to know more about the side effects this is having, although I think the industry and ACR are arguing that this is not their responsibility to research.
which has multiple causes and Axiron as a treatment.
There are plenty of other themes running both in tandem with the FDA investigation and also at the FDA, but to me this is one of the core features. The current uncertainty is about whether the FDA ramp up their concern about Axiron to the extent that it would have a detrimental effect on sales. As you point out, Q2 sales were strong, even with the cloud of uncertainty raised by the FDA investigation.

Hope this helps!

Wazz