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Bought some today of this dirt cheap stock .We could see $4++ easily with NDA filing and Runup to FDA decision (4Q16 or early 1Q2017).GL
Intellipharmaceutics(IPCI-NASDAQ, Speculative Buy, US$12 target)
Intellipharmaceutics International Inc.: Investors should focus on Rexista Oxycodone XR (pain)
targeting a US$2.3 billion market. On May 21, FDA gave guidance to IPCI that the Rexista NDA
could be filed without a Phase 3 trial if they could demonstrate bioequivalence to Oxycontin. By
IPCI only having to do a bioequivalence trial for Rexista Oxycodone XR, compared to Purdue’s Oxycontin, the company will now run a smaller trial of only 24-40 patients. IPCI should be able to file for FDA approval in H1 2016.
There are several catalysts for IPCI expected: (i) clinical results for the Rexista oxycodone
pharmacokinetic studies (fed and fasting) likely in November 2015 (ii) an NDA filing for Rexista
Oxycodone in H1 2015 (iii) 7 ANDA approvals could come at any point as the generic arm of the
FDA clears its backlog and (iv) management has been actively working on licensing its products
(generics and brand) such a transaction could be forged in H1 2016.
On May 26, FDA granted Rexista Oxycodone XR fast track designation. With a “fast track designation” for Rexista Oxycodone XR, it is possible the NDA could be reviewed in 6 months or less and the drug could be launched at the end of 2016/H1 2017 (we have modeled
in a mid 2017 to H2 2017 launch which is now very conservative).
A lifetime opp here guys
Get some beforeshe explodes higher
looks like the big rally is about to start
load up guys before the stock gets discovered . Big news like the Market launch of Natesto in july will drive this stock much higher .
Here is an undiscovered Stock with Monster Upside Potential which just trading at cash level . Aytu Biosciences bought US Rights to Natesto the only approved testosterone nasal gel which targets a $2+ BILLION Market which they start selling in July . The Company has another 3 Products on the Market and another One Big drug ready for Phase 3 . AYTU has a ridiculous Market Cap of just $13 Million which is below the Cash balance of $15 Million means you get the Company and Products for free . The Stock has minumum upside Potential of 700%+ .
In April, AYTU signed an exclusive license agreement for the U.S. commercial rights to Natesto® (testosterone) Nasal Gel. Natesto is the first and only nasal formulation of testosterone approved by the U.S. Food and Drug Administration (FDA) as a replacement therapy for men diagnosed with hypogonadism (low testosterone, or “Low T”). Aytu anticipates further expanding its current urology-centric sales force and initiating its promotion of Natesto into the $2 billion U.S. testosterone replacement market in July 2016.
Aytu Bioscience (AYTU)
Market Cap: $13.5 Million
Cash: $15 Million
Price: $0.30
Shares Out: 44.86 Million
Marketed Products:
PRIMSOL : Only FDA-approved trimethoprim oral solution; indicated for urinary tract infections
ProstaScint : Only FDA-approved imaging agent for prostate cancerdetection and staging
MIOXSYS : CE Marked in vitro diagnostic device for male infertility , Single FDA study pending
Acquired Exclusive U.S. Rights to Natesto April 2016 (US Market Launch July)
•Only FDA-approved, nasally-administered testosterone; indicated for hypogonadism
•Approved for use WITHOUT black box warning related to partner transference
ZERTANE :Phase 3-ready, effective first-in-class oral treatment for premature ejaculation
Presentation May 2016
http://aytubio.com/downloads/Aytu-Corporate-Overview.pdf
Aytu BioScience Initiates Commercial Expansion to Support July 2016 Launch of Natesto®
http://finance.yahoo.com/news/aytu-bioscience-initiates-commercial-expansion-120500542.html
Insider Buying:
May 6, 2016 DISBROW JOSHUA R. Officer direct Buy 0.40 250,000
May 6, 2016 DISBROW JARRETT Officer direct Buy 0.40 250,000
May 6, 2016 DOCKERY CARL Director indirect Buy 0.40 5,000,000
Jan 20, 2016 DISBROW JOSHUA R. Officer direct Buy 0.65 153,846
Jan 20, 2016 DISBROW JARRETT Officer direct Buy 0.65 153,846
Rallyyyyyyyyyyyyyyyyyyyyyyyyyyyyy
What an NYSE-MKT Uplisting Means for OTC Companies Like Innovus Pharma (INNV)
http://finance.yahoo.com/news/nyse-mkt-uplisting-means-otc-140000867.html
3 May 2016 - Jim Phillips presents Midatech Pharma on the Rising Stars Stage at Master Investor Show 2016
Upcoming PDUFA and ANDA Approval Dates Could Catalyze Innovus Pharma (INNV) and Lipocine (LPCN)
http://finance.yahoo.com/news/upcoming-pdufa-anda-approval-dates-140000806.html
Innovus Pharma (INNV): Targeting $3+ Billion Markets With 13 Commercial Products
http://finance.yahoo.com/news/innovus-pharma-innv-targeting-3-150320014.html
Here is a Reply from the Company :
As you know we do not control the FDA process. Therefore, any mention of timing and approvals from us relies upon some degree of speculation.
We believe we are fairly close to receiving the approvals necessary to begin marketing the product. Our best estimate is that this approval will occur sometime between June and September, allowing us to introduce the product to market during Q4 2016 or early Q1 2017.
Hope this helps. Please call or email if you have any additional questions.
Kevin Holmes
Chesapeake Group
New Recommendation
SeeThruEquity Issues Update Note on Innovus Pharmaceuticals, Inc. (OTCQB: INNV) with a Price Target of $0.80
http://finance.yahoo.com/news/seethruequity-issues-note-innovus-pharmaceuticals-130000823.html
look at page 16
Innovus Pharma Corporate Presentation – March 2016
http://www.innovuspharma.com/pdf/CorporatePresentationMarch142016.pdf
With FDA approval this low float rocket willexplode to $1 or higher
Bid going up in Pre Mkt looks like another good day ahead
up she goes guys and the market cap is still below $10 which is laughable
Major breakout to 0.20+ around the corner
FDA approval could push this low float rocket to minimum $0.50
Market cap of $6 million is a pure joke
$INNV | An Undervalued Pharma Company with Strong Commercial Pipeline and Solid Revenues
$1 stock trading at laughable 9 pennies
THIS IS A ONCE IN A LIFETIME OPPORTUNITY .The MOST underpriced Stock and lowest Market Cap (laughable $4 M) which awaiting FDA approval .
13 Marketed Products/ MEGA FDA approval for their biggest Drug Fluticare this Q / NYSE Listing in 2016
FDA approval of FlutiCare in this Quarter could push this undiscovered low float and heavily underpriced stock to minimum $0.80-$1 .
Market Cap : $3.9 M
Cash $2M untill mid 2017
Price: $0.058
Shares out: 67.6 M
Top Shareholders
http://data.cnbc.com/quotes/INNV/tab/8
Total Number of Shares Held 34.8M
Innovus Pharma Enters $1 Billion Worldwide Nasal Steroid Market with the Acquisition of FlutiCare(TM) (Fluticasone Propionate Nasal) Over The Counter ("OTC") Rights from Novalere
http://finance.yahoo.com/news/innovus-pharma-enters-1-billion-162000968.html
Innovus Pharma expects that the ANDA may be approved by the end of 2015 or in the first half of 2016 by the U.S. Food and Drug Administration ("FDA").
- FlutiCare(TM) is a nasal spray in the form that has been the #1 prescribed nasal spray to patients in the US for more than five consecutive years
- More than 40 million units of FlutiCare(TM) nasal spray product form have been sold in the U.S. in 2014
Innovus Pharma CEO Provides Shareholder Update
http://finance.yahoo.com/news/innovus-pharma-ceo-provides-shareholder-140000392.html
Emerging Markets Report: A Growing Presence in a Fast-Growing Market...Mar 16, 2016
http://www.otcmarkets.com/stock/INNV/news?id=127538
Why is Innovus Pharma a good Investment
1.Innovus Pharma has 13 commercial products
2.They started generating revenues from their sales
3.Has partners in 30 countries with over $500M in signed sales milestones
4 Has a large respiratory asset (FlutiCare) for allergic rhinitis awaiting FDA approval
5.Might be a potential target for acquisition in the near future due to their undervalued market cap
By far the biggest revenue generating product for Innovus will be FlutiCare if the OTC ANDA is approved by the FDA as it goes head to head against Flonase from GSK with a better delivery form which is the most used form in the prescription market. The Company announced over 36,000 vendors of record in the US which would give them an immediate placement in most of the retail stores in the US and immediate sales. The usual market retention of an Rx to OTC share of the market is about 15%. The current prescription form of the product is estimated to make close to $300M a year in revenues according to the Company’s last presentation at the Marcum Conference .
GREAT News
Midatech’s Commercial Launch of Zuplenz® (Ondansetron) Oral Soluble Film to Prevent Post-Operative, Chemotherapy and Radiation-Induced Nausea and Vomiting in US
http://finance.yahoo.com/news/midatech-commercial-launch-zuplenz-ondansetron-060000850.html
up she goes told you so but still brutally undervaued stock here
Big move if it breaks the $3 mark .
Steadymed’s (STDY) Buy Rating Reiterated at JMP Securities
http://www.iramarketreport.com/steadymeds-stdy-buy-rating-reiterated-at-jmp-securities/49753/
JMP Securities reiterated their buy rating on shares of Steadymed Ltd (NASDAQ:STDY) in a report issued on Wednesday morning, AnalystRatingsNetwork.com reports. JMP Securities currently has a $9.00 price target on the stock.
An institutional investor recently raised its position in Steadymed stock. Jennison Associates raised its position in Steadymed Ltd (NASDAQ:STDY) by 0.3% during the third quarter, Holdings Channel reports. The firm owned 432,255 shares of the company’s stock after buying an additional 1,159 shares during the period. Jennison Associates owned about 3.18% of Steadymed worth $1,535,000 at the end of the most recent reporting period.
Separately, RBC Capital reaffirmed a buy rating on shares of Steadymed in a research note on Monday, March 28th.
Most Insider & Institutions paid $8.50 per share you can have it at $2.70 which is a fantastic entry point near ATL . The Biotech Selloffin last weeks created this unbelievable opportunity because this stock is still unknown to most investors .
http://finance.yahoo.com/q/it?s=STDY+Insider+Transactions
Mar 25, 2015 STARK BRIAN JAY Director 1,288,112 Indirect Acquisition (Non Open Market) at $8.50 per share. 10,948,952
Mar 25, 2015 FLYNN JAMES Beneficial Owner (10% or more) 737,555 Indirect Purchase at $8.50 per share. 6,269,217
Mar 25, 2015 GINOR RON Director 1,075,102 Indirect Acquisition (Non Open Market) at $8.50 per share. 9,138,367
Mar 25, 2015 BANK KEITHDirector 2,294,283 Indirect Acquisition (Non Open Market) at $8.50 per share. 19,501,405
This Undiscovered ultra low float stock could be a Once in a Lifetime Opportunity please do your own dd and realize the MEGA Potential here .
SteadyMed (STDY) is a undiscovered stock which is close to NDA & EMA filing (expected in 4Q 2016) for their Big Orphan Drug called Trevyent® for the treatment of pulmonary arterial hypertension (PAH) . SteadyMed is trading almost at Cash Level and lots of Insider & Institutions paid over $8 per Share now trading at just $2.50 more Infos below .I think this Stock really has MEGA upside Potential .GL
SteadyMed (Nasdaq: STDY)
Market Cap: $34.9 Million
Cash: $31.8 Million
Price: $2.57
Shares Out : 13.58 Million
Insiders & Institutions holding 10.8 Million Shares
Presentation Februar 2016
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjA4MDY0fENoaWxkSUQ9MzIxMjA1fFR5cGU9MQ==&t=1
Trevyent® for pulmonary arterial hypertension (PAH)
• Combination of treprostinil and our PatchPump® platform technology
- Goal - to overcome the limitations of market leader Remodulin® (treprostinil)
- Expected NDA filing in Q3 2016
• Potential high revenue, high margin ~$180,000 per patient per year
• Potential >$4 Billion addressable market opportunity in U.S.
Bio-waiver confirmed – No clinical studies required for approval
• 505(b)(2) NDA in the U.S.
• Hybrid 10(3) Application in the E.U. - granted Centralized Review by EMA
NDA submission anticipated Q3 2016 and E.U. MAA H2 2016
Remodulin safety and efficacy data to be included in Trevyent prescribing
information
Example of FDA product approvals through bio-waiver
• Parenteral epoprostenol reformulation (Veletri®, Actelion) for PAH
Pipeline of two At-Home Patient Analgesia (AHPA) product candidates
• SMT – 201 (Ketorolac). Anticipate pivotal / registration trial H2 2016
• SMT – 301 (Bupivacaine.) Formulation development and technical feasibility ongoing
http://finance.yahoo.com/q/it?s=STDY+Insider+Transactions
Mar 25, 2015 STARK BRIAN JAY Director 1,288,112 Indirect Acquisition (Non Open Market) at $8.50 per share. 10,948,952
Mar 25, 2015 FLYNN JAMES E Beneficial Owner (10% or more) 737,555 Indirect Purchase at $8.50 per share. 6,269,217
Mar 25, 2015 GINOR RON Director 1,075,102 Indirect Acquisition (Non Open Market) at $8.50 per share. 9,138,367
Mar 25, 2015 BANK KEITH Director 2,294,283 Indirect Acquisition (Non Open Market) at $8.50 per share. 19,501,405
Top Shareholders
http://data.cnbc.com/quotes/STDY/tab/8
Total Number of Shares Held 10.8M
Some ‘cheap’ biotech stocks that could be buyout targets, RBC says
http://www.marketwatch.com/story/some-cheap-biotech-stocks-that-could-be-buyout-targets-rbc-says-2016-01-25?siteid=yhoof2
Shares of Arbutus Biopharma, SteadyMed and Endocyte are trading below cash value
---
Given that the drug is used to treat an orphan market, the profit margin for treatment in this arena is typically very high. Other orphan drugs markets can yield profit margins in the range of 20-40%. Given company estimates, the capital raised from the IPO would be enough to support approval and the final stages of development behind Trevyent. Using the conservative end of margins, 20%, and 10% market share, possible earnings would be $90 million. Then using the high growth 30x price-earnings ratio for the pharmaceutical industry, the resulting market valuation would be around $2.7 billion.
Trevyent could reach 10% market share very quickly. For example, leading competitor, Remodulin, manufactured by United Therapeutics (NASDAQ:UTHR) was approved for market in December 2013. It reached 10% share within 12 months. Given the advantages of SteadyMed's product, it should be able to at least replicate these results given the market is still largely untreated.
The Pipeline
SteadyMed's flagship drug, Trevyent, is currently in late-stage development and obtaining final approvals before going to market. The drug could treat up to 30,000 patients that suffer from PAH in the US annually. Currently, very few alternative treatments exist for PAH. The leading competitor currently only has an estimated market share of 10%. Most patients, about 80-90%, do not undergo treatment due to the difficult, cumbersome nature of the current treatment options. Trevyent and the proprietary PatchPump device promise to significantly reduce the burden of treatment, and increase accessibility. Finally, the Trevyent-PatchPump combo secures a larger share of revenue since SteadyMed sells both the drug and device. Treatment costs currently average $125k to $175k. If SteadyMed can even fetch the midpoint of this range, at a 10% market share Trevyent would be generating $450 million in sales. And, at 50% share, the drug could be a $2.3 billion drug.
Nice jump but this is just the beginning . Positive Phase 2 results of their Oral thin-film Insulin could send this low float stock over $10 easily .
-------
“Diabetes incidence is forecast to hit 500m people, globally, by 2025; with our partnered transbuccal insulin strip, MSL-001 is targeting a $20 billion market, adding significant revenue potential to our growing portfolio of products.”
Transbuccal Insulin – MidaForm™-Insulin-Pharmfilm®
Midatech’s most advanced research programme is focused on applying its GNP technology to develop a method of needle-free delivery of insulin for the treatment of diabetes. This programme takes advantage of the fact that binding a peptide hormone to a nanoparticle allows its absorption across the mucosa of the cheek.
Through its MidaSol Therapeutics joint venture with Monosol Rx, Midatech has developed a self-dissolving oral postage stamp-sized strip containing nanoparticle conjugated insulin referred to as MidaForm™-Insulin-PharmFilm®. This strip is placed on the inside of the cheek and the insulin is absorbed directly into the bloodstream via the mucous membrane of the cheek (i.e. transbuccal application). This mode of needle-free administration provides a more convenient, effective, safer and more discrete form of insulin delivery with faster onset. Midatech’s programme has the potential to offer an alternative to injections via needle for the treatment of diabetes patients.
From positive Phase I clinical trial results it has been demonstrated that the transbuccal insulin formulation is safe and well tolerated in healthy human volunteers and that it is absorbed faster and utilised more quickly than subcutaneous insulin.
•Phase I (2012) -No safety concerns
-Suggests insulin enters blood, faster to max effect
•Phase IIa-Completed in life phase January 2016
-Clinical Study Report is expected in April 2016
•Phase II data will inform strategic opportunities (license or exit)
Midatech: Building the UK’s Next Big Specialty Pharma Company...30 March 2016
http://masterinvestor.co.uk/latest/midatech-building-the-uks-next-big-specialty-pharma-company/
This undiscovered and massive underpriced stock is a must have for everyone who likes Biotech . Big News coming in April like the market launch of Zuplenz and the Phase 2 results of their Oral thin-film Insulin which targets a $20+ Billion Market .
Neil Woodford Buys More ‘Profoundly Undervalued’ Allied Minds PLC, 4d Pharma PLC And Midatech Pharma PLC
http://www.iii.co.uk/articles/303418/neil-woodford-buys-more-%E2%80%98profoundly-undervalued%E2%80%99-allied-minds-plc-4d-pharma-plc-and-?context=LSE:MTPH
Midatech Pharma
Index: FTSE AIM All-Share -- Share price: 156.5p -- Market cap: £52.4m -- Proportion of company owned by Woodford Asset Management: 20.0%
Nanomedicine company Midatech Pharma had net assets of £37.1m at 30 June 2015, so the shares are trading at 1.4 times NAV, which compares favourably with 4d Pharma's 8.3 times NAV.
Midatech also boasts some revenues, having brought in £0.4m over the 12 months to 30 June. A leap to over £8m is forecast for calendar 2016, with around £14m currently pencilled in for 2017 -- which would give a not-outrageous P/S ratio of 3.7 at the current share price.
5 Marketed Products + Oral thin-film Insulin with P2 Results in April which has Multiple Blockbuster Potential and many other drugs in clinical Trials . this undiscovered low float stock is brutally undervalued alone the marketed drugs will drive this Company into profitability within 2 years . If the Phase 2 results of the Oral Insulin in April is positive then this low float stock could explode like Oramed (ORMP) did in end 2013 to early 2014 which send the stock from $10 to almost $30 within days .
This Undiscovered Stock with a Market Cap of less than $60 Million and over $30 Million in Cash is heavily underpriced but this will Change very soon especially when the Outcome of the Oral Insulin is positive .GL
Midatech Pharma (MTP)
Market Cap: $59.5 Million
Cash: $35 Million
Price: $3.58
Shares Out: 16.6 Million
MidatechPharma US: Focus On Oncology and Supportive Care:
Zuplenz: Oral film for Chemo/Radio Rx Induced Nausea & Vomiting Highly effective 5HT3 antagonist Launch H1 2016
Gelclair: Hyaluronic Acid Oral Gel For Oral Mucositis 85-100% of H&N cancer patients on chemo/radiotherapy develop OM Leads market in US strong growth expected 2016
Aquoral:Oral Spray Treatment For Dry Mouth Xerostomia
Oravig:Buccal Tablet For Oral Candidiasis In Adults Serious complication for patients undergoing radio/chemotherapy Launched H2 2015 –first full year of sales 2016
Ferralet90: Dual Iron Delivery Anaemia treatment
Oral thin-film Insulin:
From positive Phase I clinical trial results it has been demonstrated that the transbuccal insulin formulation is safe and well tolerated in healthy human volunteers and that it is absorbed faster and utilised more quickly than subcutaneous insulin.
•Phase I (2012) -No safety concerns
-Suggests insulin enters blood, faster to max effect
•Phase IIa-Completed in life phase January 2016
-Clinical Study Report is expected in April 2016
•Phase II data will inform strategic opportunities (license or exit)
“Diabetes incidence is forecast to hit 500m people, globally, by 2025; with our partnered transbuccal insulin strip, MSL-001 is targeting a $20 billion market, adding significant revenue potential to our growing portfolio of products.”
Jim Phillips Presents on behalf of Midatech Pharma at the Biotech Capital Conference
Its going higher and higher but its still dirt cheap with a ridiculous market cap of $60 million .
“The completion of the enrollment of our pivotal Phase 3 clinical program for bronchiectasis last year was a critical achievement for Aradigm. All our efforts are now focused on having the key data analyses for both trials completed this year to enable us to file the US NDA early in 2017, followed by submission for market authorization in the European Union,” said Igor Gonda, CEO and President of Aradigm.
"Aradigm's Lipoquin and Pulmaquin inhalable antibiotics are potential best-in-class treatments designed for chronic use and to be effective at treating bacterial infections in patients' lungs, while also minimizing lung irritation that is common in cystic fibrosis and especially bronchiectasis patients," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The recent partnership with Grifols provides adequate funding to bring the program through Phase III trials in bronchiectasis and may allow Aradigm to pursue additional indications."
About Non-Cystic Fibrosis Bronchiectasis
Non-CF BE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage. Non-CF BE represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the U.S. and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.
Undiscovered ARDM is one of the cheapest Biotechs out there which has MONSTER Upside Potential . If Pulmaquin is successful in Phase 3 in 2H 2016 then this low float rocket has the Potential to move Close to $100 per Share .Pulmaquin has QIDP,Orphan Drug and Fast Track Status and there is no approved Drug for Bronchiectasis .
Market Cap: $47 Million
Cash Balance : $39.9 Million
Shares Out : 14.73 Million
Pipeline
http://www.aradigm.com/products_pipeline.html
Aradigm Corporation Completes Enrollment in the Second Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-3)
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=936283
Aradigm Corporation Completes Enrollment in Phase III Study of Pulmaquin in Non-Cystic Fibrosis Bronchiectasis (ORBIT-4)
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=932534
Grifols and Aradigm Corporation Complete the Closing of Worldwide Licensing Agreement to Develop and Commercialize Pulmaquin®
http://investor.aradigm.com/releasedetail.cfm?ReleaseID=787555
Full Analysis
https://www.baystreet.ca/articles/research_reports/lifesci/266497b2-3c17-408a-91b8-f40e7d3ad3cf.pdf
Licensing Agreement with Grifols Validates Aradigm’s Inhaled Antibiotic Approach. In May 2013, Aradigm announced an exclusive worldwide licensing agreement with Grifols (NasdaqGS:GRFS) covering both of Aradigm’s proprietary, liposomal formulations of ciprofloxacin, Lipoquin and Pulmaquin.The deal provides up to $65 million for developmental and clinical expenses related to the BE indication. Aradigm can receive an additional $25 million in development milestones. Grifols is responsible for commercialization upon FDA and EU approvals. Aradigm will receive tiered royalties on worldwide sales of 12.5% on the first $300 million annually, and increasing to 20% above that. Aradigm will also receive a transfer price mark-up on the supplied product. Grifols also received an option to license Aradigm’s AERx® pulmonary drug delivery platform for another drug, and made a $26 million investment in Aradigm. Grifols is a Spanish multinational pharmaceutical company with over $5 billion in sales for 2012, and almost 75 years of experience selling, promoting, and distributing healthcare products. Grifols is an ideal partner with experience in respiratory indications in the US, and has a successful 25 year track record selling Prolastin-C for patients with emphysema due to deficiency of alpha1-proteinase inhibitor. Grifols, along with existing and new investors, also led a $41.4 million round of financing that greatly extends Aradigm’s cash runway, and will allow the Company to focus on the execution of its clinical trials for BE and other indications.
Pulmaquin's Potential
Bronchiectasis is observed in patients with cystic fibrosis on a frequent basis. However, it is less common in patients without cystic fibrosis. According to Aradigm, non-cystic fibrosis bronchiectasis affects more than 110,000 people in the U.S. As a result, Pulmaquin was granted orphan drug designation by the FDA in June 2011. The orphan drug status means that if approved, Pulmaquin can command a higher price. Also, in the U.S., there are no drugs approved right now for the treatment of bronchiectasis. The incidence of bronchiectasis is growing at 9% a year in the U.S. In Europe, the disease affects 210,000 patients. According to Igor Gonda, president and CEO of Aradigm, Pulmaquin for bronchiectasis is a billion-dollar plus opportunity globally.
The Company is close to profitability and with 5 more products to enter the Market within next 12 Months and plus more inlicensing of Products ,this Company will be a cash cow .
Pediapharma has a Marketcap of just C$22 Million thats a big joke for such great Company but you need experience to realize the big potential here .
This Undiscovered Company has 6 Drugs on Market and 5 under review by Health Canada . The Game Changer for Pediapharm is Easyhaler which expected to approved before year end .Another reason to own the Stock is the upcoming US-Partnership for Naproxen which also expected before year end . This Stock is a Lifetime Opportunity .
Pediapharm (PDP)
MarketCap: C$ 22.2 Millionen
Cash: $5.5 Millionen
Price: $0.31
Nice Summary (Fact Sheet)
http://www.pedia-pharm.com/wp-content/themes/ifeature-tpl/PDF/PDP_Fact_sheet_oct_26_2015.pdf
Pediapharm has submitted its reconsideration package to Health Canada regarding Easyhaler Budesonide. The Company’s objective remains to obtain a marketing approval by the end of 2015.
Furthermore, before the end of 2015, the Company intends to sign an agreement with a US commercial partner for the selling and marketing of its first product acquisition in the US; namely the Pediapharm Naproxen Suspension. Pediapharm believes that with this agreement, the Company will reach profitability more rapidly.
REALLY then why FDA says that Telesta can file BLA on existing clinical trial data set ???????
MCNA U.S. Regulatory Update
Following several months of active dialogue with the U.S. Food and Drug Administration (FDA), concerning the most appropriate regulatory pathway for MCNA approval in the United States, Bioniche has received written guidance. This guidance provides
regulatory clarity and permits the submission of an MCNA Biological License Application (BLA) for U.S. marketing approval review based on Bioniche's existing clinical trial data set.
Billion Dollar Cancer Drug close to FDA approval if approved then this Stock could be a 10 Bagger .GL
ADCOM on November 18
FDA Decision in 1Q 2016
Telesta Therapeutics (BNHLF) (TST.TO)
Marketcap$115 Million
Cash $45 Million
Price: 0.40
Telesta Therapeutics: Near-Term Catalyst Could Provide Multi-Bagger Returns
http://seekingalpha.com/instablog/592211-john-h-ford/4491146-telesta-therapeutics-near-term-catalyst-could-provide-multi-bagger-returns
Valuation summary (all share prices in US dollars)
· Fair valuation today: $300 million. Shareprice: $1.04.
· Fair valuation following positive advisory committee recommendation: $600 million. Shareprice: $2.08.
· Fair valuation following 2nd Phase 3 trial recommendation: $150 million. Shareprice: $.52.
· For valuation following 2nd phase 3 trial recommendation with concurrent FDA approved drug sales: valuation $400 million. Shareprice: $1.38.
· Fair valuation following FDA approval: $1 billion. Shareprice: $3.47.
· Fair valuation long-term following FDA approval: $3 billion to $4.5 billion. Shareprice: $10.41 to $15.62.
Telesta is currently trading in the $.30 range in the US, so any of the above scenarios would provide significant returns. The only caveat, is that if a 2nd phase 3 trial is recommended, the company could trade well under fair valuation for a period of time.
Telesta provides 3 opportunities that could generate short-term multi-bagger returns:
· Telesta is so undervalued that with any level of Wall Street awareness, the share price could be driven higher. As we get closer to November 18, the shareprice could rise in anticipation of a positive recommendation.
· When the company reports the results of the FDA's advisory committee, if the results are positive, the share price should rise again.
· In February we will learn whether or not the FDA has approved Telesta's lead drug. With FDA approval, Telesta should be worth at least $1 billion and I would expect buyout offers in that range.
FDA precedent has already been established with Valstar's approval, and I believe MCNA with its superior clinical results will be approved in February. In effect, this is an opportunity to buy a soon to be $1 billion company, for $90 million, a true Buffett trade.
NBY ($0.88) got FDA approval today ..could run to $2++
RDHL close to a Major Breakout guys
RedHill Biopharma to Host Investor Webcast Forum Following Completion of RHB-105 Dosing in Phase III Study
http://finance.yahoo.com/news/redhill-biopharma-host-investor-webcast-110000092.html
RedHill will host an interactive investor forum on H. pylori bacterial infection and RHB-105, on Thursday, May 14, 2015, at 8:00-9:30 am Eastern Time. Participants are invited to join the forum through the Company's website or by telephone
RHB-105 dosing has been completed in the blinded stage of the ERADICATE Hp study - a randomized, placebo-controlled, first Phase III study evaluating RHB-105 as a first-line therapy for H. pylori bacterial infection - a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and MALT lymphoma
Top-line results from the ERADICATE Hp Phase III study with RHB-105 are expected in mid-end June 2015. The primary endpoint of the study is superiority over historical standard of care efficacy levels of 70% effectiveness