Lipocine (NASDAQ:LPCN) held its post action meeting with the FDA’s Division of Bone, Reproductive and Urologic Products in mid-January and recently received the minutes of the meeting. On February 24th the company announced that, according to FDA feedback, it will be able to address the remaining outstanding deficiency through reanalysis of existing data. This avoids the time and expense of an additional trial. The outstanding deficiency was the failure of the trial endpoints to fall within the guideline ranges for maximal testosterone concentrations (Cmax). It appears that Lipocine was able to convince the FDA through further analysis that the data fell within required parameters.
In a prior report, we noted that the FDA guidelines call for 85% of subjects to achieve a Cmax below 1500 ng/dL and no more than 5% of subjects to present a Cmax between 1800 ng/dL and 2500 ng/dL and 0% above 2500 ng/dL. In the most recent dosing validation (DV) study, 85% of subjects were below 1500 ng/dL and 7% were between 1800 ng/dL and 2500 ng/dL. It was unclear whether all data from Lipocine’s clinical trials were included in the reanalysis or just a subset from the most recent study.
Based on the interactions with the FDA and the follow up minutes subsequently provided, it appears that the agency is amenable to reviewing another NDA submission for Tlando. During the post action meeting with the FDA, Lipocine presented the reanalyzed data and made the argument that Tlando is comparable to other approved products. After reviewing the information, the representatives from the FDA indicated that the data and analysis was reasonable. No changes to the label are anticipated based on the interaction.
As provided in the February 24 press release, a 1Q:20 resubmission is expected and a six-month review will ensue. This suggests a PDUFA date in September 2020. Between now and then we expect the pace of discussion with potential partners to pick up; however, no announcements of deals are expected until a favorable response is given.
In other news, enrollment continues in the NASH trials and there is expected to be an announcement when milestones are reached. Regarding the patent infringement trial, it has been postponed due to a conflict on the part of the judge. Previously, the trial was anticipated to start in August 2020, but now is expected in 1Q:21. The delay will allow Lipocine to focus its management and financial resources on Tlando at about the time the FDA announces their verdict.
Following the announcement of the imminent resubmission, Lipocine announced today a $6 million capital raise at an offering price of $0.595 per unit. The deal will attach one half warrant per share at a $0.53 exercise price. Closing is expected February 27, 2020.
While nothing is certain until approval is granted, the news that resubmission will occur in the next few weeks and the FDA looked favorably on the presentation of additional analysis is positive. It has been a long difficult road to advance Tlando to the finish line and it appears that we may reach that point this fall.
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