Lipocine Inc

 

http://globenewswire.com/news-release/2015/01/12/...egnant-Women.html  

haben ja ein phase 3 medikament im petto  

ob mal wieder was geht... bald...  

 

positive topline efficacy results
http://mobile.reuters.com/article/idUSFWN1JG0JY  

"On June 19, 2017, Lipocine Inc. issued a press release announcing topline results from the Dosing Validation study and the Dosing Flexibility study for LPCN 1021. The press release is filed as Exhibit 99.1 and is incorporated herein by reference."

Quelle:
https://www.sec.gov/Archives/edgar/data/1535955/...029/v469221_8k.htm

....da simma dabei das is priiima.... :)))  

13 zu 6 Panel-Voting das die Risiken den Nutzen übersteigen. Das sieht nicht gut aus. Die FDA Entscheidung wird für den 8. May erwartet. Watchlist.

https://www.forbes.com/sites/arleneweintraub/2018/...gs/#2363d2d43a4c  

sieht ganz gut aus
https://www.lipocine.com/pipeline/  

Panel Voting sieht es anders  

oh wird hier wieder fleissig gekauft, ok den Run bis PDUFA kann man ja machen....


da muss ich Vassago beipflichten das Panel tat sich ja dagegen entschieden..
wird eine fast unmögliche Nr. am 08.Mai


The final vote came in at 6 to 13 recommending the FDA not approve the drug

https://finance.yahoo.com/news/...-lpcn-fails-convince-220728349.html  

FDA sagt "Nein"

https://endpts.com/...da-shows-another-testosterone-therapy-the-door/

 

sah günstig aus  

https://www.ariva.de/news/...didate-achieves-meaningful-liver-7359027  

LPCN 1144

http://ir.lipocine.com/2019-01-17-Lipocines-NASH-Therapy-Candidate-Achieves-Meaningful-Liver-Fat-Reduction-Based-on-Interim-Results

Allerdings gibt es Kritik am Studiendesign:

"I could conduct another webinar on clinical trial red flags based solely on todays LPCN liver fat study press release. Missing patients (and too few overall), no placebo control, skewed means, arbitrary data cutoffs, etc etc. "

https://twitter.com/adamfeuerstein/status/1085877664991178753

 

 

 

 

LPCN 1144

wieder Kritik von AF:

"Not that anyone trading cares, but today’s LPCN iver fat (NASH? NAFLD? Something else?) data are worse than the data previously disclosed in January. Also, wow, so many changes to endpoint definitions. Carry on…."

https://twitter.com/adamfeuerstein/status/1105446714276761600

 

 

 

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. $