What do you guys make of this article blurb? The FDA has already denied the application for Tlando once, but Lipocine is preparing to try for approval once again, relying on similar data from the original rejected application.
A drawback for the oral administration of Tlando is that patients will be required to keep a consistent diet, maintaining certain fat content and calorie intake. And this is the case for each dosing. If patients fail to adhere to specific dietary requirements, patients are unlikely to see a meaningful rise in testosterone levels, which would be a huge problem and a potential marketing nightmare for the product. A significantly more adverse scenario is that during the company's FDA studies, a handful of men reached testosterone levels of over 2500 ng/dl, which is both extremely high and dangerous.
In addition to potential FDA problems looming for Tlando, the company itself said in a press release that LPCN 1021 (Tlando) only "generally met" the prespecified per dose secondary endpoints for twice daily oral administration.
In layman's terms, the product either meets the endpoint or it doesn't, and when the company itself publishes mixed messages, investors should pay close attention. Also important to note is that the FDA will be highly unappeased if men being treated by Tlando exceed the 2500 ng/dl level, making the chances for approval unlikely. And to add insult to potential misery, as far as the FDA is concerned, when endpoints are "generally met," product support is unlikely. The FDA's words, not mine.
The biggest issue for Tlando compared to Natesto, though, is that when placed side by side, Tlando does not get as many men to normal testosterone levels. Company-sponsored studies demonstrate a significant edge in benefit from Natesto with 90% of males reaching normal testosterone levels, compared to just 70% of patients reaching normal testosterone levels when using Tlando. The FDA has made it known that at least 75% of men taking the testosterone product must reach normal T levels so it is difficult to understand how the FDA would even approve Tlando. Additionally, with Tlando known to produce dangerously high testosterone concentrations in some men, the road to approval may be far tougher than even the most optimistic investor may be willing to admit.
