When it comes to biotechs, all it takes is a single spark to ignite the flame. For Lipocine (LPCN), which is focused on metabolic and endocrine disorders, this spark could be a fast-approach regulatory decision. The company is gearing up for Tlando’s PDUFA date, currently scheduled for August 28.Writing for H.C. Wainwright, analyst Oren Livnat tells clients that Tlando, the company’s oral testosterone replacement therapy (TRT), has had a “long regulatory saga” that features two complete response letters (CRLs).That being said, based on multiple factors, Livnat is cautiously optimistic that the FDA will give the therapy its final stamp of …read more
Source:: Yahoo Finance
