Lipocine Inc

FDA verweigert TLANDO zum dritten Mal die Zulassung

https://endpts.com/...ir-oral-testosterone-drug-snubbed-again-by-fda/

Glückwunsch 

6 Mio. $ Offering

• 12 Mio. neue Aktien zu je 0,50$ ~ 6 Mio. $
  

Was für schlechtes Timing vom Management. Finger weg!

https://ir.lipocine.com/...blic-Offering-Of-Common-Stock-And-Warrants

• neues 52 WT
  
• MK 12 Mio. $
  

6 Mio. $ Offering

• 10 Mio. neue Aktien zu je 0,595$ ~ 6 Mio. $
  

https://ir.lipocine.com/...tered-Direct-Offering-Priced-At-The-Market

28. August PDUFA für Tlando

Der vierte Versuch?

FDA benötigt zusätzliche Zeit

"Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has informed the Company that it needs additional time to complete its review of TLANDO's New Drug Application ("NDA") and is committed to taking action as expeditiously as possible.  The anticipated Prescription Drug User Food Act ("PDUFA") goal date was August 28, 2020 for TLANDO. Although the FDA did not provide a timeline on a new action date, the FDA informed the Company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional data and the Company has provided the FDA with all information requested to date.

TLANDO is the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism."

https://ir.lipocine.com/...e-Provides-Regulatory-Update-for-TLANDO-TM

FDA erteilt die "vorläufige" Zulassung für Tlando

• eine endgültige Zulassung und Vermarktung in den USA kann erst dann erfolgen, wenn die Exklusivitätsfrist für das von Clarus Therapeutics entwickelte Konkurrenzprodukt Jatenzo am 27. März 2022 abläuft
  
• zudem muss LPCN bestimmte Studien nach dem Inverkehrbringen durchführen um wichtige Risiken im Zusammenhang mit Tlando besser bewerten zu können
  

https://www.rttnews.com/3152093/...tosterone-replacement-therapy.aspx

25 Mio. $ Offering

• 14,3 Mio. neue Aktien zu je 1,75$
  

https://ir.lipocine.com/...derwritten-Public-Offering-Of-Common-Stock