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Up she goes
A run to $5.50-6 before FDA decision is possible
PSDV is MASSIVE oversold (RSI 21) a rebound could start any minute now ...
Just 9 days to go untill FDA Decision .GL
Hello Guys
Its time to get into PSDV ..FDA Decision in just 10 days
Psivida (PSDV)
Market Cap $119
Cash $18 M
Price $4.10
Shares Out: 29.2 M ( 12 M shares held by Insiders & Institutions)
PDUFA date in 16 Days (Sep 26) FDA approval + $25 M Payment = Double Digits Coming
PSDV will move into double digits after FDA approval and it will help to push the Company deep into Profitability .
Pfizer is third largest Shareholder of PSDV holding 1.9 M Shares
“We are very optimistic for our lead partnered product, ILUVIEN for DME. The New Drug Application (NDA) was refiled earlier this year, with a resulting Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014. Our licensee, Alimera Sciences, entered into labeling discussions with the FDA, and we await the FDA’s decision with anticipation. We are entitled to a $25.0 million milestone payment if ILUVIEN is approved by the FDA and 20% of any net profits from sales by Alimera on a country-by-country basis.”
DME is a potentially blinding disease that affects over one million people in the United States. The U.S. market for DME is $1.5 billion to $4 billion.
FDA Decision in 10 days ..Time to load up guys ...
Psivida (PSDV)
Market Cap $119
Cash $18 M
Price $4.10
Shares Out: 29.2 M ( 12 M shares held by Insiders & Institutions)
PDUFA date in 16 Days (Sep 26) FDA approval + $25 M Payment = Double Digits Coming
PSDV will move into double digits after FDA approval and it will help to push the Company deep into Profitability .
Pfizer is third largest Shareholder of PSDV holding 1.9 M Shares
“We are very optimistic for our lead partnered product, ILUVIEN for DME. The New Drug Application (NDA) was refiled earlier this year, with a resulting Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014. Our licensee, Alimera Sciences, entered into labeling discussions with the FDA, and we await the FDA’s decision with anticipation. We are entitled to a $25.0 million milestone payment if ILUVIEN is approved by the FDA and 20% of any net profits from sales by Alimera on a country-by-country basis.”
DME is a potentially blinding disease that affects over one million people in the United States. The U.S. market for DME is $1.5 billion to $4 billion.
Big Run to $2++ could start any day now ..just around 50 days untill FDA Decision ..
BNC.TO (MC $40 M) BLA Filing in 1Q for Bladder Cancer vaccine
The Drug is effective and has great safety Profile and im sure it will work even on other types of cancer because Bladder Cancer is one of the hard to treat .. MarketCap of around $40 M (includes the current Share Offering) is very very cheap for a Biotech who has a big cancer Drug that completes all clinical studies successfully .
I think a price target of $2 within 12-18 months is realistic ....
Bioniche Life Science (BNC.TO) << Canadian Stock
Market Cap $40 M
Cash $15 M
Price $0.21
Bioniche Announces Q1/2015 Timeline for the Filing of a Biologics License Application for Marketing Approval of MCNA in the United States..
http://finance.yahoo.com/news/bioniche-announces-q1-2015-timeline-120000914.html
Latest Presentation
http://www.bioniche.com/pdf/2014/Bioniche%20Non-Conifidential%20Presentation%20June%202014.pdf
MCNA Phase 3 Study-Summary
Bioniche completed an open-label, single-arm Phase 3 trial with MCNA suspension.
Objective was to evaluate the efficacy and safety of MCNA in patients with
NMIBC at high risk of recurrence and progression who had failed BCG therapy
Total of 129 patients with high grade papillary and/or carcinoma insitu (CIS) who had failed (refractory or relapse) to respond to one or more courses of BCG were enrolled across 25 centers in U.S. and Canada
.
MCNA-Phase 3 Overview Strong Potential as Salvage Therapy
25% overall DFS rate at 1 year
35% DFS rate in patients with papillary tumors only at 1 year
Response to MCNA treatment provides several additional clinical benefits
•Based on post-study analyses benefits included:
•Long duration of response
•Reduced rate of cystectomies
•Reduced risk of progression
Excellent safety and tolerability profile
Most adverse events reported were mild to moderate in severity.
No special handling or disposal required
Market Potential
The Company has conducted an internal assessment of the potential available patients in the U.S. on a yearly basis, using a watershed/stratification of published NMIBC epidemiology data and guidance from urologists experienced in the treatment of the disease. Based on internal analyses, the Company projects that there are approximately 8,500 new available patients in the U.S. each year. Based on these patient number assumptions, and making certain estimates of drug pricing, unit volume and market penetration rates, the Company estimates that in the U.S. the market potential for MCNA in BCG-failures could approach $200 million per year. The Company is in the process of engaging an external firm with expertise in market research, commercial assessment and market access (pricing and reimbursement) in order to validate these internal estimates and obtain sales forecasts based on various commercial scenarios.
Read more at http://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#gExUb8gpcy8sdFJm.99
BNC.TO (MC $40 M) BLA Filing in 1Q for Bladder Cancer vaccine
The Drug is effective and has great safety Profile and im sure it will work even on other types of cancer because Bladder Cancer is one of the hard to treat .. MarketCap of around $40 M (includes the current Share Offering) is very very cheap for a Biotech who has a big cancer Drug that completes all clinical studies successfully .
I think a price target of $2 within 12-18 months is realistic ....
Bioniche Life Science (BNC.TO) << Canadian Stock
Market Cap $40 M
Cash $15 M
Price $0.21
Bioniche Announces Q1/2015 Timeline for the Filing of a Biologics License Application for Marketing Approval of MCNA in the United States..
http://finance.yahoo.com/news/bioniche-announces-q1-2015-timeline-120000914.html
Latest Presentation
http://www.bioniche.com/pdf/2014/Bioniche%20Non-Conifidential%20Presentation%20June%202014.pdf
MCNA Phase 3 Study-Summary
Bioniche completed an open-label, single-arm Phase 3 trial with MCNA suspension.
Objective was to evaluate the efficacy and safety of MCNA in patients with
NMIBC at high risk of recurrence and progression who had failed BCG therapy
Total of 129 patients with high grade papillary and/or carcinoma insitu (CIS) who had failed (refractory or relapse) to respond to one or more courses of BCG were enrolled across 25 centers in U.S. and Canada
.
MCNA-Phase 3 Overview Strong Potential as Salvage Therapy
25% overall DFS rate at 1 year
35% DFS rate in patients with papillary tumors only at 1 year
Response to MCNA treatment provides several additional clinical benefits
•Based on post-study analyses benefits included:
•Long duration of response
•Reduced rate of cystectomies
•Reduced risk of progression
Excellent safety and tolerability profile
Most adverse events reported were mild to moderate in severity.
No special handling or disposal required
Market Potential
The Company has conducted an internal assessment of the potential available patients in the U.S. on a yearly basis, using a watershed/stratification of published NMIBC epidemiology data and guidance from urologists experienced in the treatment of the disease. Based on internal analyses, the Company projects that there are approximately 8,500 new available patients in the U.S. each year. Based on these patient number assumptions, and making certain estimates of drug pricing, unit volume and market penetration rates, the Company estimates that in the U.S. the market potential for MCNA in BCG-failures could approach $200 million per year. The Company is in the process of engaging an external firm with expertise in market research, commercial assessment and market access (pricing and reimbursement) in order to validate these internal estimates and obtain sales forecasts based on various commercial scenarios.
Read more at http://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#gExUb8gpcy8sdFJm.99
Thats the area where i will sell half of my position .
I think $2.50-$3 before FDA decision is achievable and if approved then it can go to $4 or higher .
Another good day ahead for AEZS ...
We have around 65 days untill PDUFA date so means enough time to move much higher from this massive undervalued level .
STRONG Accumulation ongoing Stock price will follow very quickly ..
AEZS runnning higher guys
PDUFA date on November 5
Market Cap just $75 M
Cash : $40 M
Cheapest FDA play out there for 2014
AEZS runnning higher guys
PDUFA date on November 5
Market Cap just $75 M
Cash : $40 M
Cheapest FDA play out there for 2014
No Cheaper FDA Play out there for 2014 .. AEZS will move much higher the close we move to the FDA Decision .
More good News for BNC.TO and nice move to 0.37 but still massivly undervalued .
Bioniche Announces Submission of Orphan Drug Designation Application for MCNA in the United States
http://finance.yahoo.com/news/bioniche-announces-submission-orphan-drug-120000542.html
More good News for BNC.TO and nice move to 0.37 but still massivly undervalued .
Bioniche Announces Submission of Orphan Drug Designation Application for MCNA in the United States
http://finance.yahoo.com/news/bioniche-announces-submission-orphan-drug-120000542.html
BNC.TO ..Very BIG BIG Surprise for the Company because of the fantastic News from FDA on last Friday . FDA says they can File for Marketing Approval just based on Bioniche's existing clinical trial data set. Management itself thought they need to conduct another Phase 3 Study .
The Drug called MCNA for Bladder Cancer has HUGE Market Potential and it could be on the Market within 1H 2015 if it gets Priority Review .The Market Cap of $42 Million is really a Big Joke and the key point is that not many people have this pure Goldmine on their Radar .
Bioniche is already in discussions with Potential Partner means we can expect nice upfront payments i think $25-40 M is realistic .
Bioniche is definitely one of the cheapest Cancer Play i ever have seen before .GL
Bioniche Life Science (BNC.TO) (BNHLF)
Market Cap: $42 M
Cash: $12.2 M
Price: $0.29
Bioniche Announces Intention to File for Marketing Approval of MCNA in the United States (July 18)
http://finance.yahoo.com/news/bioniche-announces-intention-file-marketing-120000955.html
Presentation from June
http://www.bioniche.com/pdf/2014/Bioniche%20Non-Conifidential%20Presentation%20June%202014.pdf
From latest Earnings (May 2014)
http://finance.yahoo.com/news/bioniche-life-sciences-inc-reports-210000339.html
the Company has approximately $12.2 million in cash and cash equivalents. This represents approximately 14 months of operations for the Company, based upon including the first escrow payment of $0.6 million and the anticipated positive working capital adjustment of $2.4 million from Vétoquinol."
BNC.TO ..Very BIG BIG Surprise for the Company because of the fantastic News from FDA on last Friday . FDA says they can File for Marketing Approval just based on Bioniche's existing clinical trial data set. Management itself thought they need to conduct another Phase 3 Study .
The Drug called MCNA for Bladder Cancer has HUGE Market Potential and it could be on the Market within 1H 2015 if it gets Priority Review .The Market Cap of $42 Million is really a Big Joke and the key point is that not many people have this pure Goldmine on their Radar .
Bioniche is already in discussions with Potential Partner means we can expect nice upfront payments i think $25-40 M is realistic .
Bioniche is definitely one of the cheapest Cancer Play i ever have seen before .GL
Bioniche Life Science (BNC.TO) (BNHLF)
Market Cap: $42 M
Cash: $12.2 M
Price: $0.29
Bioniche Announces Intention to File for Marketing Approval of MCNA in the United States (July 18)
http://finance.yahoo.com/news/bioniche-announces-intention-file-marketing-120000955.html
Presentation from June
http://www.bioniche.com/pdf/2014/Bioniche%20Non-Conifidential%20Presentation%20June%202014.pdf
From latest Earnings (May 2014)
http://finance.yahoo.com/news/bioniche-life-sciences-inc-reports-210000339.html
the Company has approximately $12.2 million in cash and cash equivalents. This represents approximately 14 months of operations for the Company, based upon including the first escrow payment of $0.6 million and the anticipated positive working capital adjustment of $2.4 million from Vétoquinol."
NEW Buy Rating by Brean Capital from today ....
Intellipharmaceutics Intl. Inc. July 17, 2014 (IPCI/ NASDAQ)
Jonathan Aschoff,
Rexista Technology Is Differentiated - A Look At The Rexista Patent Filing (Buy TP: $8.00)
Investment Summary
A recently published patent application describes Intellipharmaceutics’ abuse-deterrent oral formulation.
The patent document clearly shows that Rexista, which at present is oxycodone or oxymorphone delivered
via Intellipharmaceutics’ proprietary oral formulation, is more resistant to abuse techniques (such as
crushing, milling, pulverizing, grinding, heating, and microwaving) than OxyContin, a commercially available
market leading extended release oxycodone. We look forward to results from the second Phase 1
trial in 2H14, after which Phase 3 may be initiated. By showing similar results with both oxycodone
and oxymorphone versus their respective commercially available equivalents, Intellipharmaceutics has
demonstrated the broad utility of its formulation technology. We therefore believe that this novel
technology will be able to reduce the abuse potential for other opioids such as hydromorphone and
morphine.
Discussion
A recently published patent application describes Intellipharmaceutics’ abuse-deterrent oral formulation.
The patent document clearly shows that Rexista, which at present is oxycodone or oxymorphone delivered
via Intellipharmaceutics’ proprietary oral formulation, is more resistant to abuse techniques (such as
crushing, milling, pulverizing, grinding, heating, and microwaving) than OxyContin, a commercially available
market leading extended release oxycodone. We look forward to results from the second Phase 1 trial in
2H14, after which Phase 3 may be initiated.
Exhibit 1 shows that Rexista better retained its shape when subjected to 350N force than did OxyContin,
and therefore Rexista should be more difficult than OxyContin to abuse through crushing. When pulverized/
milled and reduced to particles as shown in Exhibit 2, Rexista appeared to be difficult and time consuming
to abuse through injecting or inhaling through the nose or mouth.
Also, Rexista is more resistant to a practice known as “dose dumping” through which a drug releases
large portions of its active ingredient over a short period of time.
Exhibit 3 demonstrates that Rexista
slowly released oxycodone in a variety of media. Exhibit 4 shows that Rexista dissolved more quickly than
OxyContin in acidic (0.1NHCL) media at every time point over the 24-hour period, which is meant to simulate
the acidity of the stomach and therefore demonstrate Rexista's ability to deliver a quick loading dose (within
30 minutes) when taken properly. Specifically, Rexista dissolved only about 40% in acid versus 50% for
OxyContin after one hour. Moreover, with the addition of 40% alcohol in the acid, Rexista dissolved only
less than 10% after 2 hours and about 20% after 4 hours, demonstrating that there is no dosing dumping
effect with Rexista in alcohol.
Exhibits 6 and 7 show that pulverized Rexista released oxycodone more slowly than did pulverized OxyContin in Coca-Cola (another acidic solution) and in water. Pulverized Rexista dissolved only less than 20% in Coca-Cola after 1 hour while pulverized OxyContin dissolved 40% in Coca-Cola after 1 hour, with
the difference in dissolution being greatest after 4 hours. In water, pulverized Rexista released oxycodone
gradually while pulverized OxyContin dissolved quickly during a short period of time. Rexista is also more resistant to being microwaved, another common method of abusing oxycodone. As
shown in Exhibit 8, Rexista demonstrated almost no dissolution when microwaved for 2 minutes both in
acid alone and in acid plus alcohol. In contrast, OxyContin showed 90% dissolution in acid 2 hours after
being microwaved for 2 minutes and 90% dissolution in acid plus alcohol 3 hours after being microwaved
for 2 minutes.
Similarly, Intellipharmaceutics has formulated a Rexista using oxymorphone as the API and it showed the
same characteristics versus the commercially available equivalent Opana, thereby demonstrating the broad
utility of the company's formulation technology. We therefore believe that this novel technology will be
able reduce the abuse potential for other opioids such as hydromorphone and morphine.
Valuation / Target Price
We derive our target price of $8 for IPCI through a DCF analysis, using a 35% discount rate and a 5 multiple
of the terminal value for the projected 2022 EBITDA.
Nice Rebound on IPCI .. I think we will see $3.30-3.50 within days and much higher on News like FDA approval or New Partnerships .GL
looks like Selloff is done now watch for a rebound to over $3++ quickly
IPCI is wayyy oversold here
Some Insider Buying not much but i think more buying will happen in the coming days ...
http://canadianinsider.com/node/7?menu_tickersearch=i
Jul 10/14 Jul 10/14 Madhani, Bahadur Direct Ownership Common Shares 10 - Acquisition in the public market 1,000 $3.11
Jul 10/14 Jul 10/14 Madhani, Bahadur Direct Ownership Common Shares 10 - Acquisition in the public market 500 $3.10
IPCI is at current price one of the most attractive and cheapest Biotech out there and IPCI is massive oversold with an RSI of 27 .
IPCI has 7 ANDA´s awaiting FDA approval 4 of them exceed the 36 Month average approval time by many months means FDA approvals could come any day now . They have another two Mega Drugs called Rexista & Regabatin which are ready to enter Phase 3 later this year .
Float is around 10 M and they have a low Market Cap of just $66 M makes IPCI one of the most attractive Play in the US Biotech Sector .
This Low Float Gem has the Potential to run into Double Digits with FDA approvals which means Deep Profitability for IPCI .GL
Market-Cap: $66 M
Cash: $7.2 M
Burn-Rate: $1.5 M per Quarter
Shares Out: 23.3 M
Monster Pipeline:
http://www.intellipharmaceutics.com/pipeline.cfm
New Fact Sheet:
http://files.shareholder.com/downloads/ABEA-43EQSZ/3274879952x0x763239/4201830c-54e1-47cb-bc3b-97ffa0248cd9/IPCI_June_Fact_Sheet.pdf
We currently have seven Abbreviated New Drug Applications awaiting FDA approval.
These include generics of Effexor XR®, Protonix ®' Glucophage ® XR,Seroquel XR®, Lamictaf® XR Keppra XR® and Pristiq® .
Together, these products represent approximately $4.1 billion of branded and generic sales.
The company received approval of its first generic product, Focalin XR, in November 2013 and its marketing partner Par Pharmaceutics immediately launched the drug at the end of November 2013. The company has a total of seven controlled-release generic drugs that are awaiting FDA approval.
IPCI is at current price one of the most attractive and cheapest Biotech out there and IPCI is massive oversold with an RSI of 27 .
IPCI has 7 ANDA´s awaiting FDA approval 4 of them exceed the 36 Month average approval time by many months means FDA approvals could come any day now . They have another two Mega Drugs called Rexista & Regabatin which are ready to enter Phase 3 later this year .
Float is around 10 M and they have a low Market Cap of just $66 M makes IPCI one of the most attractive Play in the US Biotech Sector .
This Low Float Gem has the Potential to run into Double Digits with FDA approvals which means Deep Profitability for IPCI .GL
Market-Cap: $66 M
Cash: $7.2 M
Burn-Rate: $1.5 M per Quarter
Shares Out: 23.3 M
Monster Pipeline:
http://www.intelliphar maceutics.com/images/Pipeline.png
New Fact Sheet:
http://files.shareholder.com/downloads/ABEA-43EQSZ/3274879952x0x763239/4201830c-54e1-47cb-bc3b-97ffa0248cd9/IPCI_June_Fact_Sheet.pdf
We currently have seven Abbreviated New Drug Applications awaiting FDA approval.
These include generics of Effexor XR®, Protonix ®' Glucophage ® XR,Seroquel XR®, Lamictaf® XR Keppra XR® and Pristiq® .
Together, these products represent approximately $4.1 billion of branded and generic sales.
The company received approval of its first generic product, Focalin XR, in November 2013 and its marketing partner Par Pharmaceutics immediately launched the drug at the end of November 2013. The company has a total of seven controlled-release generic drugs that are awaiting FDA approval.
IPCI is at current price one of the most attractive and cheapest Biotech out there and IPCI is massive oversold with an RSI of 27 .
IPCI has 7 ANDA´s awaiting FDA approval 4 of them exceed the 36 Month average approval time by many months means FDA approvals could come any day now . They have another two Mega Drugs called Rexista & Regabatin which are ready to enter Phase 3 later this year .
Float is around 10 M and they have a low Market Cap of just $66 M makes IPCI one of the most attractive Play in the US Biotech Sector .
This Low Float Gem has the Potential to run into Double Digits with FDA approvals which means Deep Profitability for IPCI .GL
Market-Cap: $66 M
Cash: $7.2 M
Burn-Rate: $1.5 M per Quarter
Shares Out: 23.3 M
Monster Pipeline:
http://www.intelliphar maceutics.com/images/Pipeline.png
New Fact Sheet:
http://files.shareholder.com/downloads/ABEA-43EQSZ/3274879952x0x763239/4201830c-54e1-47cb-bc3b-97ffa0248cd9/IPCI_June_Fact_Sheet.pdf
We currently have seven Abbreviated New Drug Applications awaiting FDA approval.
These include generics of Effexor XR®, Protonix ®' Glucophage ® XR,Seroquel XR®, Lamictaf® XR Keppra XR® and Pristiq® .
Together, these products represent approximately $4.1 billion of branded and generic sales.
The company received approval of its first generic product, Focalin XR, in November 2013 and its marketing partner Par Pharmaceutics immediately launched the drug at the end of November 2013. The company has a total of seven controlled-release generic drugs that are awaiting FDA approval.
Selling at this hard undervalued level could be a big mistake especially when the stock starts to run .
UP 10% in Pre Mkt and over 200(MA) now ..Looking great
http://www.nasdaq.com/symbol/aezs/premarket
AEZS (Mcap $67M) (Cash $46M) PDUFA Date November 5 ..Next Hot Play guys
This Stock is one of the cheapest in the Biotech Sector . They have $45.7 M in Cash and a Market Cap of just $67 M thats ridiculous for a Company with such a Mega Pipeline .Another good sign is that Management bought 187k Shares in last few weeks .This is the Perfect time to load up before the speculators jumping in .
FDA decision on November 5 (Macrilen) and Interim Phase 3 results in 1H 2015 (ZoptEC) !
AEZS could run to $3-5 before FDA decision in early November .GL
Aeterna Zentaris (AEZS)
Market Cap: $67 M
Cash: $45.7 M
Price: $1.18
Shares Out: 56.5 M
Insider activity:
http://canadianinsider.com/node/7?menu_tickersearch=aez
Jun 10/14 Jun 10/14 Egbert, Carolyn Direct Ownership Common Shares 10 - Acquisition in the public market 100,000 $1.10 USD
Apr 14/14 Apr 11/14 Dodd, David Alan Direct Ownership Common Shares 10 - Acquisition in the public market 87,000 $1.15 USD
Pipeline
http://www.aezsinc.com/en/page.php?p=20
New Presentation
http://www.aezsinc.com/pdfdyn/AEZS%20presentation%20June%202014.pdf
MACRILEN™(macimorelin)
•Filing of a New Drug Application ("NDA") seeking approval for the commercialization of MACRILEN™ as the firstavailable oral product indicated for the evaluation of Adult Growth Hormone Deficiency
. NDA currently undersubstantive review by the US Food and Drug
Administration with a Prescription Drug User Fee Act date of November 5,2014
Zoptarelin doxorubicin
Operate trial in support of achieving first interim analysis for
ZoptEC Phase 3 trial in H1-2015
AEZS (Mcap $67M) (Cash $46M) PDUFA Date November 5
This Stock is one of the cheapest in the Biotech Sector . They have $45.7 M in Cash and a Market Cap of just $67 M thats ridiculous for a Company with such a Mega Pipeline .Another good sign is that Management bought 187k Shares in last few weeks .This is the Perfect time to load up before the speculators jumping in .
FDA decision on November 5 (Macrilen) and Interim Phase 3 results in 1H 2015 (ZoptEC) !
AEZS could run to $3-5 before FDA decision in early November .GL
Aeterna Zentaris (AEZS)
Market Cap: $67 M
Cash: $45.7 M
Price: $1.18
Shares Out: 56.5 M
Insider activity:
http://canadianinsider.com/node/7?menu_tickersearch=aez
Jun 10/14 Jun 10/14 Egbert, Carolyn Direct Ownership Common Shares 10 - Acquisition in the public market 100,000 $1.10 USD
Apr 14/14 Apr 11/14 Dodd, David Alan Direct Ownership Common Shares 10 - Acquisition in the public market 87,000 $1.15 USD
Pipeline
http://www.aezsinc.com/en/page.php?p=20
New Presentation
http://www.aezsinc.com/pdfdyn/AEZS%20presentation%20June%202014.pdf
MACRILEN™(macimorelin)
•Filing of a New Drug Application ("NDA") seeking approval for the commercialization of MACRILEN™ as the firstavailable oral product indicated for the evaluation of Adult Growth Hormone Deficiency
. NDA currently undersubstantive review by the US Food and Drug
Administration with a Prescription Drug User Fee Act date of November 5,2014
Zoptarelin doxorubicin
Operate trial in support of achieving first interim analysis for
ZoptEC Phase 3 trial in H1-2015
AEZS (Mcap $67M) (Cash $46M) PDUFA Date November 5
This Stock is one of the cheapest in the Biotech Sector . They have $45.7 M in Cash and a Market Cap of just $67 M thats ridiculous for a Company with such a Mega Pipeline .Another good sign is that Management bought 187k Shares in last few weeks .This is the Perfect time to load up before the speculators jumping in .
FDA decision on November 5 (Macrilen) and Interim Phase 3 results in 1H 2015 (ZoptEC) !
AEZS could run to $3-5 before FDA decision in early November .GL
Aeterna Zentaris (AEZS)
Market Cap: $67 M
Cash: $45.7 M
Price: $1.18
Shares Out: 56.5 M
Insider activity:
http://canadianinsider.com/node/7?menu_tickersearch=aez
Jun 10/14 Jun 10/14 Egbert, Carolyn Direct Ownership Common Shares 10 - Acquisition in the public market 100,000 $1.10 USD
Apr 14/14 Apr 11/14 Dodd, David Alan Direct Ownership Common Shares 10 - Acquisition in the public market 87,000 $1.15 USD
Pipeline
http://www.aezsinc.com/en/page.php?p=20
New Presentation
http://www.aezsinc.com/pdfdyn/AEZS%20presentation%20June%202014.pdf
MACRILEN™(macimorelin)
•Filing of a New Drug Application ("NDA") seeking approval for the commercialization of MACRILEN™ as the firstavailable oral product indicated for the evaluation of Adult Growth Hormone Deficiency
. NDA currently undersubstantive review by the US Food and Drug
Administration with a Prescription Drug User Fee Act date of November 5,2014
Zoptarelin doxorubicin
Operate trial in support of achieving first interim analysis for
ZoptEC Phase 3 trial in H1-2015
EDAP ..Buy Rating $6 TGT
http://www.streetinsider.com/Analyst+Comments/H.C.+Wainwright+Starts+EDAP+TMS+S.A.+%28EDAP%29+at+Buy/9584148.html?si_client=st
Analyst Swayampakula Ramakanth said, "The medical ultrasound device market is believed to be about $6 billion. The company, operational since 1979, has a steady revenue stream from its base UDS division that markets lithotripters for kidney stone removal and a growing HIFU business commercializing focused ultrasound devices, Ablatherm and Focal One. Both Ablatherm and Focal One with CE markings are designed to treat localized prostate cancer in a minimally invasive manner yet with precision. Recently, the European Association of Urology recommended the use of HIFU technology as both primary and salvage therapy for localized prostate cancer. An additional shot in the arm came in the form of recent French and Swiss governments' decisions to reimburse HIFU based technology. EDAP's PMA for FDA approval of Ablatherm is currently under review and is scheduled to be evaluated by a panel on July 30th. We expect a positive FDA decision and launch of Ablatherm by the end of 2014. In our opinion, EDAP is poised to become a profitable company by the end of 2015 and represents an undervalued stock with significant upside for the long-term value investor."
Strong Accumulation in last 2 days looks like next big leg is around the corner
Ralllyyyyyyyyyyyyy $4 here we come
Target $5-7 before ADCOM
(EDAP) ADCOM on July 30 ...I think EDAP has the potential to run 50-100% just before ADCOM and could hit $8-10 on positive outcome .US approval would drive EDAP deep into Profitability .
Market Cap: $81 M
Cash: $18 M
Shares Out: 24.8 M
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
http://finance.yahoo.com/news/edaps-ablatherm-hifu-fda-panel-123000701.html
http://www.cancerfactorfiction.com/prostate-cancer/hifu-success-rates/
http://www.hifu.ca HIFU has high success rates with the 700 patients treated at the Maple Leaf HIFU clinic. Over 300,000 patients have been treated worldwide by HIFU, with 10 years of documented success for treating prostate cancer with Ablatherm HIFU – High Intensity Focused Ultrasound.
(EDAP) ADCOM on July 30 ...I think EDAP has the potential to run 50-100% just before ADCOM and could hit $8-10 on positive outcome .US approval would drive EDAP deep into Profitability .
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
http://finance.yahoo.com/news/edaps-ablatherm-hifu-fda-panel-123000701.html
http://www.cancerfactorfiction.com/prostate-cancer/hifu-success-rates/
http://www.hifu.ca HIFU has high success rates with the 700 patients treated at the Maple Leaf HIFU clinic. Over 300,000 patients have been treated worldwide by HIFU, with 10 years of documented success for treating prostate cancer with Ablatherm HIFU – High Intensity Focused Ultrasound.
Looks like Big Breakout is around the corner
We could hit $4+ this Week .. Stock getting stronger and stronger
ADCOM on July 30 ...I think EDAP has the potential to run 50-100% just before ADCOM and could hit $8-10 on positive outcome .US approval would drive EDAP deep into Profitability .
EDAP
Marktet Cap: $81 M
Cash: $18 M
Shares Out: 24.8 M
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
http://finance.yahoo.com/news/edaps-ablatherm-hifu-fda-panel-123000701.html
http://www.cancerfactorfiction.com/prostate-cancer/hifu-success-rates/
http://www.hifu.ca HIFU has high success rates with the 700 patients treated at the Maple Leaf HIFU clinic. Over 300,000 patients have been treated worldwide by HIFU, with 10 years of documented success for treating prostate cancer with Ablatherm HIFU – High Intensity Focused Ultrasound.
ADCOM on July 30 ...I think EDAP has the potential to run 50-100% just before ADCOM and could hit $8-10 on positive outcome .US approval would drive EDAP deep into Profitability .
EDAP
Marktet Cap: $81 M
Cash: $18 M
Shares Out: 24.8 M
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
http://finance.yahoo.com/news/edaps-ablatherm-hifu-fda-panel-123000701.html
http://www.cancerfactorfiction.com/prostate-cancer/hifu-success-rates/
http://www.hifu.ca HIFU has high success rates with the 700 patients treated at the Maple Leaf HIFU clinic. Over 300,000 patients have been treated worldwide by HIFU, with 10 years of documented success for treating prostate cancer with Ablatherm HIFU – High Intensity Focused Ultrasound.
ADCOM on July 30 ...I think EDAP has the potential to run 50-100% just before ADCOM and could hit $8-10 on positive outcome .US approval would drive EDAP deep into Profitability .
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
http://finance.yahoo.com/news/edaps-ablatherm-hifu-fda-panel-123000701.html
http://www.cancerfactorfiction.com/prostate-cancer/hifu-success-rates/
http://www.hifu.ca HIFU has high success rates with the 700 patients treated at the Maple Leaf HIFU clinic. Over 300,000 patients have been treated worldwide by HIFU, with 10 years of documented success for treating prostate cancer with Ablatherm HIFU – High Intensity Focused Ultrasound.
PDUFA Date May 28 for CompleoTRT & Important Phase 2 results for Potential blockbuster Tefina .. This Stock has 200-300% in near term Potential .(Ticker TRLPF or TRL.TO ) .GL
After years of development and clinical trials, the NDA final step is nearing an end with the PDUFA of May 28. All the hard work and sacrifice is looking to pay off in a big way in 2014.
Most shareholders are in this at a much higher level than the current price. Everyone knows there is a big event coming soon (FDA decision) and an approval from the FDA will be huge for this stock.
Testosterone is a well characterized molecule, thus the regulatory requirements for approval are less stringent than a typical NCE (new chemical element).
Topical gels are primarily used to treat Low "T" in the US and run the risk of transference to family members. Thus, all of the products have black box warnings. If approved, CompleoTRT has a much lower risk of transference and is unlikely to have the warning. This distinguishing characteristic should aid in marketing efforts once approved.
The US Testosterone market is very large and relatively untapped. The US market is currently valued at $2 Billion and growing despite only about 10% of addressable men currently treated.
The top selling low "T" drug is Androgel which had a staggering $1.373 Billion in sales over the past 4 quarters, in the US alone !
This stock is tightly held with First Generation Capital and other insiders holding more than half the shares.
RBC Capital Markets gives the stock an Outperform rating with a 12 month target of $1.50. I think this is low. I could see TRL over $2.00 with an FDA approval of Compleo and the naming of a good partner.
On top of all this, Tefina (which is the equivalent of female viagara) with blockbuster potential, is nicely developing in the wings.
Lots to like here with the FDA to make a decision by May 28.