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As Lipocine's $LPCN-1021 nears its FDA PDUFA date for a deficiency or absence of endogenous testosterone ("hypogonadism") what is the drug's potential?
http://slingshotinsights.com/projects/208
As Lipocine's $LPCN-1021 nears its FDA PDUFA date for a deficiency or absence of endogenous testosterone ("hypogonadism") what is the drug's potential?
http://slingshotinsights.com/projects/208
As Lipocine's $LPCN-1021 nears its FDA PDUFA date for a deficiency or absence of endogenous testosterone ("hypogonadism") what is the drug's potential?
http://slingshotinsights.com/projects/208
As Lipocine's $LPCN-1021 nears its FDA PDUFA date for a deficiency or absence of endogenous testosterone ("hypogonadism") what is the drug's potential?
http://slingshotinsights.com/projects/208
Lpath, Inc.: Drug Approval Decision
LPCN 1021, Lipocine Inc’s (NASDAQ:LPCN) lead product candidate, also known as Tlando, is an oral testosterone supplement for adult males with a deficiency or absence of endogenous testosterone. It is currently under FDA review with a deadline of June 28 to be approved or denied. Analysts are encouraged that the FDA has not called for an Advisory Committee meeting. Lipocine has $38.2 million in cash without any FDA-approved products, though analysts hope that will change this month.
Michael Higgins of Roth Capital reassured that the FDA did not request an Advisory Committee meeting to discuss the drug, noting that this “encouraging signal” paves the way for Tlando approval. Coupled with recent publications highlighting the drug’s strong safety profile, Higgins has reason to be optimistic for the FDA’s decision.
Higgins continues to model a marketing partnership into his evaluation, estimating a $40 million upfront payment. He elaborates, “Management is leaving all options on the table, from launching Tlando itself, to retaining co-promotion rights to a full marketing rights agreement. We peg the odds of these marketing strategies at 15%, 25% and 60%, respectively.”
Separately, Nisha Hirani of Zacks Capital Research is also bullish on the company’s prospects with Tlando. Nisha echoes Higgins’ optimism about the FDA bypassing an Advisory Committee meeting because it means the “FDA does not need any independent expert advise regarding the LPCN 1021 data that Lipocine has submitted…Not having an AdComm will save Lipocine significant time and costs associated with hiring outside consultation for this activity.”
Read more: Important Catalysts Approaching for These Biotechs | Investopedia http://www.investopedia.com/articles/insights/060216/important-catalysts-approaching-these-biotechs.asp#ixzz4AQvRzb5W
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Lpath, Inc.: Drug Approval Decision
LPCN 1021, Lipocine Inc’s (NASDAQ:LPCN) lead product candidate, also known as Tlando, is an oral testosterone supplement for adult males with a deficiency or absence of endogenous testosterone. It is currently under FDA review with a deadline of June 28 to be approved or denied. Analysts are encouraged that the FDA has not called for an Advisory Committee meeting. Lipocine has $38.2 million in cash without any FDA-approved products, though analysts hope that will change this month.
Michael Higgins of Roth Capital reassured that the FDA did not request an Advisory Committee meeting to discuss the drug, noting that this “encouraging signal” paves the way for Tlando approval. Coupled with recent publications highlighting the drug’s strong safety profile, Higgins has reason to be optimistic for the FDA’s decision.
Higgins continues to model a marketing partnership into his evaluation, estimating a $40 million upfront payment. He elaborates, “Management is leaving all options on the table, from launching Tlando itself, to retaining co-promotion rights to a full marketing rights agreement. We peg the odds of these marketing strategies at 15%, 25% and 60%, respectively.”
Separately, Nisha Hirani of Zacks Capital Research is also bullish on the company’s prospects with Tlando. Nisha echoes Higgins’ optimism about the FDA bypassing an Advisory Committee meeting because it means the “FDA does not need any independent expert advise regarding the LPCN 1021 data that Lipocine has submitted…Not having an AdComm will save Lipocine significant time and costs associated with hiring outside consultation for this activity.”
Read more: Important Catalysts Approaching for These Biotechs | Investopedia http://www.investopedia.com/articles/insights/060216/important-catalysts-approaching-these-biotechs.asp#ixzz4AQvRzb5W
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$LPCN looks like the run up going into FDA date June 28, 2016 starts today.
$LPCN looks like the run up going into FDA date June 28, 2016 starts today.
great hair cut NASDAQ:KMPH
3 Companies Filed For Chapter 11 Bankruptcy Today ... welcome to OTC
http://www.benzinga.com/news/16/05/7914494/3-companies-filed-for-chapter-11-bankruptcy-today#ixzz47bPuK5mN
San Francisco Will Require Solar Panels On New Buildings..
http://samuel-warde.com/2016/04/san-francisco-will-require-solar-panels-new-buildings/
$SRPT nice haircut today.
--Advisory Committee Meeting Rescheduled for April 25, 2016--
-FDA date for eteplirsen is May 26, 2016--
Lipocine Vs. Antares: Who Wins?
http://seekingalpha.com/article/3966615-lipocine-vs-antares-wins
This is better- SunEdison Inc (SUNE) Bankruptcy: Not So Easy ...
http://www.bidnessetc.com/67467-sunedison-sune-bankruptcy-not-so-easy/
SunEdison Could Overcome Its Liquidity Issues...
Summary
It seems all but imminent that SunEdison (SUNE) will file Chapter 11.
We believe that there is a coherent case for SunEdison to avoid bankruptcy filings.
Should the company not file for bankruptcy we believe SunEdison could increase 40.0x in value.
http://seekingalpha.com/article/3966332-sunedison-april-15-2016-8-k-debtor-possession-financing-analysis?app=1&auth_param=1a433e:1bhcukc:60d3628ff6e59bf80572465d0300b902&uprof=45&dr=1#alt2
10K or BK ....what's your take on?
No fraud doesn't mean no BK; but a new clean 8K means no BK; because if there were a BK, this 8K would have included BK clause.
VSLR getting investigated by SEC (tit for tat)
no pain no gain
all sideliners are in today, as little hope of no BK
SunEdison in talks to sell India solar stakes to Fortum - sources
http://in.reuters.com/article/sunedison-inc-india-idINKCN0XB19P
Horror? Romance? Comedy? SUNE is like a movie
check out SUNE's twin sisters GLBL and TERP ....rocking too in pre-market
cool and gang playing music in the back ground and signing Dire Strait's oh ya once upon a time in the west and SUNE climbing, perfect combination
who is going to millionaires on this one? me for sure and guess what, my investment in tax free account. yahhhhhhhhhhhhhhhhhhoooooooooo
shorties remember never play with hedgies
AT opening bell $2
SUNE is on fire in pre-market
shorties gonna take the pps to $5. and our billionaires hedge fund friends will play with them
Next...
1) Chattila step down
2) GLBL asset swap
3) VSLR Settlement
4) Indian asset sale
5) 10-k
6) Alchemists stone
Boom $5!
SUNE pre-market on fire
Does a shareholder lose all of their equity once a Chapter 11 bankruptcy is filed by the company?
http://www.investopedia.com/ask/answers/10/stock-holder-lose-equity-chapter-11.asp
$BTU, largest coal miner in the world, seeks bankruptcy protection today. Trading halt at present.
http://www.wsj.com/articles/peabody-energy-files-for-chapter-11-protection-from-creditors-1460533760
$BTU, largest coal miner in the world, seeks bankruptcy protection today. Trading halt at present. I just hope it is not the same with SUNE.
http://www.wsj.com/articles/peabody-energy-files-for-chapter-11-protection-from-creditors-1460533760
SUNE hired the "best bankruptcy team" for "restructuring".
Update: Obama Launches Solar Energy Job Program For 50,000 Veterans
http://samuel-warde.com/2015/04/obama-launches-solar-energy-job-program-50000-veterans/
$LPCN: Awaiting June PDUFA Date ..
http://finance.yahoo.com/news/lpcn-awaiting-june-pdufa-date-150000075.html
$LPCN: Awaiting June PDUFA Date ..
http://finance.yahoo.com/news/lpcn-awaiting-june-pdufa-date-150000075.html
First oral TRT option under FDA review PDUFA goal date of June 28, 2016
product targeting ~$2.0 Billion established US market
http://files.shareholder.com/downloads/AMDA-2BVSIV/1840697421x0x881108/9521E3DD-F9C3-4529-B9D3-74F6ACF78801/March_Corp_Presentation_031016-mvp.pdf
SunEdison Reporting Issues: TerraForm Power 8-K Discloses Good News
http://seekingalpha.com/article/3963676-sunedison-reporting-issues-terraform-power-8-k-discloses-good-news