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Looks like some retail investors misread the purchase agreement with lincoln park fund they thought it means dilution immediately but thats just an agreement to sell up to $15 milion of shares during a 30 month period .So this create a nice buying opp again .
http://secfilings.nasdaq.com/filingFrameset.asp?FilingID=12304039&RcvdDate=9/29/2017&CoName=TONIX%20PHARMACEUTICALS%20HOLDING%20CORP.&FormType=8-K&View=html
KTOV & TNXP the cheapest and hottest Bio Gems for the next 6-9 months
Great News out ,they got their FDA acceptance
https://finance.yahoo.com/news/kitov-announces-filing-fda-drug-110000894.html
Another green day maybe it will hit $5 today
trading below cash , very low market cap of only $33 million , only 7.5 million shares outstanding , Baker bros one of the most successful investors in sector ups their stake , attractive product in advanced phase 3 trial with results in 1H 2018 , $650 million sales potential = A MEGA OPPORTUNITY HERE it will move up faster the closer we get to the phase3 results .
Tonix Pharmaceuticals Presented at the 2nd Annual Cohen Veterans Care Summit in Washington, D.C.
https://finance.yahoo.com/news/tonix-pharmaceuticals-presented-2nd-annual-110000131.html
once it breaks $4.50 then it will jump to $5++ quickly
IF P3 is successful then this stock could hit $80-100 per share (= Mcap $600-750M) thats not much for a Drug with $650 million potential.GL
Tonix's Tonmya Treats PTSD By Helping Sufferers Sleep Better ..Sep.27.17
https://seekingalpha.com/article/4109815-tonixs-tonmya-treats-ptsd-helping-sufferers-sleep-better
Summary
PTSD is a serious illness that has devastating symptoms. It affects 3.5% of American adults, or 8.6m individuals each year. The prevalence of PTSD is even higher among veterans.
The only FDA approved PTSD drug treatment, the SSRIs (selective serotonin reuptake inhibitors), failed to show efficacy in military-related PTSD and have serious side effects.
Tonix's Tonmya is being studied in HONOR, a phase 3 trial for treating military-related PTSD. Tonmya works by improving sleep quality and allowing the mind to heal itself.
This article focuses on PTSD and discusses how Tonmya can meet a very important unmet medical need.
they did a reverse split back in march buddy
TNXP (MC $30 M)Cash $34 M /O/S 7.5 M / Phase 3 Data in 1H 2018 =10+ Bagger Potential !!
Another terrible undervalued stock for you guys which trading below Cash and which is close to phase 3 readout if successfull the drug will have around $600+ Million in Sales Potential . The Company has only 7.5 Million Shares outstanding and Baker bros who are really one of the most successful investors in the Biotech Sector is second largest shareholder . TNXP should be valued right now around $15 per share for their Phase 3 program and huge cash balance and if phase 3 outcome is positive then sky is the limit .GL
Tonix Pharma (TNXP)
Market Cap: $30 Million
Cash: $34.5 Million
Kurs: $4.05
Shares Out: 7.5 Million
New Presentation
http://content.equisolve.net/tonixpharma/media/5834b932b328c4417b28ea179cb3f7c8.pdf
Phase 3 HONOR study of Tonmya in military-related PTSD enrolling
•Encouraging evidence of safety and efficacy was demonstrated in Phase 2
Breakthrough Therapy designation from U.S. Food and Drug Administration (FDA)
•Expedited development and accelerated review are expected
•Potential to file NDA based on one Phase 3 study if data are statistically persuasive
Proposed registration plan agreed by the FDA
•Additional nonclinical safety and clinical abuse potential studies are not required
Patent protection through 2034 in U.S.
•Composition of matter patent for eutectic, required for transmucosal delivery of cyclobenzaprine
TNXP: Patient Enrollment Continues for Phase 3 Study of Tonmya® in PTSD; Interim Analysis Expected in 1H18
http://scr.zacks.com/News/Press-Releases/Press-Release-Details/2017/TNXP-Patient-Enrollment-Continues-for-Phase-3-Study-of-Tonmya-in-PTSD-Interim-Analysis-Expected-in-1H18-article/default.aspx
Conclusion and Valuation
The U.S. military’s intense interest in identifying safe and effective PTSD treatments is important for Tonix, as the AtEase study is the only controlled clinical trial to show a benefit in treating military related PTSD. If those results can be duplicated in the HONOR study (and Tonmya® gets approved), the Department of Defense and the VA would likely be very interested in getting the treatment to military personnel and veterans who suffer from PTSD.
Our valuation for Tonix is derived from a probability adjusted discounted cash flow model that takes into account potential future revenues from the sale of TNX-102 SL in PTSD. Of the approximately 8.6 million individuals in the U.S. who suffer from PTSD, it’s estimated that approximately 20% seek treatment. With a peak market share of only 6%, we currently estimate that peak sales of $650 million are possible. Using a discount rate of 18% and a 50% probability of approval leads to a net present value for the PTSD program of $67 million. Combined with the company’s current cash position and dividing by a reasonable fully diluted share count of 8.1 million shares leads to a valuation of approximately $13 per share.
Insider & Institutional Ownership :
Rosalind Advisors, Inc. 553 908
Baker Bros. Advisors LP 510 922
B. Riley Capital Management LLC 378 138
Opaleye Management, Inc. 370 000
Empery Asset Management LP 315 000
The Vanguard Group, Inc. 184 377
Heights Capital Management, Inc. 89 713
Seth Lederman, MD 83 400
Ernest Mario, PhD 69 718
Kingdon Capital Management LLC 64 549
TNXP (MC $32M)Cash $34M /O/S 7.5 M / Phase 3 Data in 1H 2018 =More than just cheap .
Another terrible undervalued stock for you guys which trading below Cash and which is close to phase 3 readout if successfull the drug will have around $600+ M Market Potential . The Company has only 7.5 Million Shares outstanding and Baker bros who are really one of the most successful investors in the Biotech Sector is second largest staekholder . TNXP should be valued right now around $15 per share for their Phase 3 program and huge cash balance and if phase 3 outcome is positive then sky is the limit .GL
Tonix Pharma (TNXP)
Market Cap: $32 Million
Cash: $34.5 Million
Kurs: $4.25
Shares Out: 7.5 Million
New Presentation
http://content.equisolve.net/tonixpharma/media/5834b932b328c4417b28ea179cb3f7c8.pdf
Phase 3 HONOR study of Tonmya in military-related PTSD enrolling
•Encouraging evidence of safety and efficacy was demonstrated in Phase 2
Breakthrough Therapy designation from U.S. Food and Drug Administration (FDA)
•Expedited development and accelerated review are expected
•Potential to file NDA based on one Phase 3 study if data are statistically persuasive
Proposed registration plan agreed by the FDA
•Additional nonclinical safety and clinical abuse potential studies are not required
Patent protection through 2034 in U.S.
•Composition of matter patent for eutectic, required for transmucosal delivery of cyclobenzaprine
TNXP: Patient Enrollment Continues for Phase 3 Study of Tonmya® in PTSD; Interim Analysis Expected in 1H18
https://finance.yahoo.com/news/tnxp-patient-enrollment-continues-phase-161500725.html
Conclusion and Valuation
The U.S. military’s intense interest in identifying safe and effective PTSD treatments is important for Tonix, as the AtEase study is the only controlled clinical trial to show a benefit in treating military related PTSD. If those results can be duplicated in the HONOR study (and Tonmya® gets approved), the Department of Defense and the VA would likely be very interested in getting the treatment to military personnel and veterans who suffer from PTSD.
Our valuation for Tonix is derived from a probability adjusted discounted cash flow model that takes into account potential future revenues from the sale of TNX-102 SL in PTSD. Of the approximately 8.6 million individuals in the U.S. who suffer from PTSD, it’s estimated that approximately 20% seek treatment. With a peak market share of only 6%, we currently estimate that peak sales of $650 million are possible. Using a discount rate of 18% and a 50% probability of approval leads to a net present value for the PTSD program of $67 million. Combined with the company’s current cash position and dividing by a reasonable fully diluted share count of 8.1 million shares leads to a valuation of approximately $13 per share.
Insider & Institutional Ownership :
Rosalind Advisors, Inc. 553 908
Baker Bros. Advisors LP 510 922
B. Riley Capital Management LLC 378 138
Opaleye Management, Inc. 370 000
Empery Asset Management LP 315 000
The Vanguard Group, Inc. 184 377
Heights Capital Management, Inc. 89 713
Seth Lederman, MD 83 400
Ernest Mario, PhD 69 718
Kingdon Capital Management LLC 64 549
Nice move yesterday ..
Small Phase 2b trial has huge chance to be successful because it was already successfull in prior studies so this stock like to be above $10 after phase 2 results in early Q1 . And that Management holding 15+ million shares of the 24.3 million shares outstanding makes me also optimistic .GL
MDNA55 is enrolling patients in a Phase 2b clinical trial for rGB at leading brain cancer centres in the US. MDNA55 has completed 3 clinical trials in 72 patients, including 66 adults with rGB, demonstrated compelling efficacy and obtained Fast-Track and Orphan Drug status from USFDA. Unlike most other cancer therapies, Medicenna's IL4-ECs have the potential to purge both the tumor and the immunosuppressive tumor microenvironment,
Medicenna Phase 2b trial using Brainlab technology
http://www.biotuesdays.com/briefs/2017/6/8/medicenna-phase-2b-trial-using-brainlab-technology
The current Phase 2b clinical trial plans to enroll 43 adult patients with rGB at leading brain cancer centers in the U.S.
MDNA.TO (MC C$36 M) (Cash C$20 M) Hot Cancer Play with important Results in Q1 that could lead to FDA approval
Brutally cheap and completely unknown canadian biotech stock with minimum 10 bagger potential . Positive Phase 2 results in recurrent glioblastoma which expected in Q1 2018 could lead to accelerated approval which would be a HUGE MAJOR milestones for this undiscovered low float stock . This company has brutally low valuation of only $36 million and most of that in cash $20 million which is enough untill Q1 2019 . This stock at $1.50 is a lifetime opportunity and we could see $15-20 easily on Positive 2 results and FDA approval .GL
Medicenna Therapeutics (MDNA.TO)
Market Cap C$36 Million
Cash : C$ 20 Million << enough untill Q1 2019
Price : $1.50
Shares Out: 24.3 Million ( 15.5 Million shares held by Insider alone )
Medicenna Therapeutics (TSXV: MDNA) CEO: Our Drug Has Potential for Phase 2 Approval
https://smallcappower.com/videos/companies-to-watch/medicenna-therapeutics-tsxv-mdna/
New Presentation
http://s21.q4cdn.com/710416940/files/doc_presentations/2017/Medicenna-Corporate-Presentation-Q3-2017.pdf
Fact Sheet
http://s21.q4cdn.com/710416940/files/doc_downloads/fact_sheet/Medicenna-FS-Q1-2017-v2.pdf
Insider Ownership :
Aries Biologics, Inc. 5 500 000
Rosemina Merchant 5 050 000
Fahar Merchant 5 050 000
Elizabeth Williams 5 300
Chandrakant J. Panchal, PhD 1 000
Trevor P. Wong-Chor 714
$1 coming closer
Great News out , if this Drug also works in Phase 3 (results expected next year) then this one will be the next Billion Dollar Company ,this unknown stock should be valued at $5 right now for their phase 3 asset .GL
Soleno Therapeutics Presents Updated Safety and Efficacy Data from Clinical Trial of DCCR for Treatment of Prader-Willi Syndrome
https://finance.yahoo.com/news/soleno-therapeutics-presents-updated-safety-120000410.html
Sonoma Pharmaceuticals Announces Commercialization of MicrocynAH® Animal Healthcare Products in Japan
https://finance.yahoo.com/news/sonoma-pharmaceuticals-announces-commercialization-microcynah-080500768.html
Analysts Offer Insights on Healthcare Companies: Soleno Therapeutics Inc (NASDAQ: SLNO) and Alexion Pharmaceuticals (NASDAQ: ALXN)
http://www.analystratings.com/articles/analysts-offer-insights-on-healthcare-companies-soleno-therapeutics-inc-nasdaq-slno-and-alexion-pharmaceuticals-nasdaq-alxn/#more-502551
There’s a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Soleno Therapeutics Inc (NASDAQ: SLNO) and Alexion Pharmaceuticals (NASDAQ: ALXN) with bullish sentiments.
Soleno Therapeutics Inc (NASDAQ: SLNO)
Maxim Group analyst Gabrielle Zhou assigned a Buy rating to Soleno Therapeutics Inc (NASDAQ: SLNO) today and set a price target of $5. The company’s shares opened today at $0.62.
Zhou noted:
“Soleno today announced the issuance of a new patent (9,757,384) from the U.S. Patent and Trademark Office for the use of pharmaceutical formulations of diazoxide and diazaxide choline (Diazoxide Choline Controlled Release Tablet; DCCR) to reduce aggressive behaviors in patients with Prader-Willi syndrome (PWS) or Smith-Magenis syndrome (SMS).”
this stock will explode to $1++ anytime now ...
Great News out stock exploding in pre market ..
Soleno Therapeutics Announces Issuance Of New U.S. Patent For DCCR In Treatment Of Prader-Willi Syndrome
https://www.biospace.com/News/soleno-therapeutics-announces-issuance-of-new-u-s/469152
Great buying opp today
Once we break the MA (200) at 0.69 then $1+ coming quickly .
https://stockcharts.com/c-sc/sc?s=slno&p=D&yr=0&mn=9&dy=0&i=p93834726544&r=3658
and back up again ...
SLNO (MC $26 M) BLOCKBUSTER in Phase 3 /Rare Disease +Orphan Status /$2+ BILLION Market = REAL Unknown low float stock with 1000% upside Potential and more .Next billion dollar rare disease company like SRPT here .GLTA
Soleno therapeutics (SLNO)
Market Cap $26 Million
Cash: $8 Million
Price $0.54
Shares Out: 47.6 Million ( 36 Million shares held by Insiders & Institutions)
Initiating Coverage June 26, 2017
http://www.lifescicapital.com/wp-content/uploads/Soleno.pdf
•Company expects to initiate pivotal Phase III clinical trial by year-end 2017; will take approximately 9-12 months to complete
Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase III clinical development program at the end of 2017.
Market Opportunity for PWS is Substantial.
While the lack of approved treatments for PWS alone make it difficult to assess the market, sales of Pfizer’s (NYSE: PFE)
Genotrop in (somatropin) can provide some insight despite being indicate for PWS, in addition to, growth failure due to growth hormone deficiency(GHD),Turner syndrome,idiopathic short stature,and small for gestational age.This product achieved its highest revenue in 2008,with worldwide sales of approximately $900 million.While somatropin has been proven to improve growth and body composition, it does not affect the key disease component of hyperphagia and use is associated with substantial risk. Soleno is developing DCCR for the treatment of PWS,to help address the unmet need of this patient population. To assess the potential of DCCR for PWS, we performed a scenario analysis, which indicates that annual sales could be in the range of $1.1 billion given a moderate price point and 50% market penetrance.
SLNO (MC $26 M) BLOCKBUSTER in Phase 3 /Rare Disease +Orphan Status /$2+ BILLION Market = REAL Unknown low float stock with 1000% upside Potential and more .Next billion dollar rare disease company like SRPT here .GLTA
Soleno therapeutics (SLNO)
Market Cap $26 Million
Cash: $8 Million
Price $0.54
Shares Out: 47.6 Million ( 36 Million shares held by Insiders & Institutions)
Initiating Coverage June 26, 2017
http://www.lifescicapital.com/wp-content/uploads/Soleno.pdf
•Company expects to initiate pivotal Phase III clinical trial by year-end 2017; will take approximately 9-12 months to complete
Soleno Therapeutics, Inc. (Soleno) is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase III clinical development program at the end of 2017.
Market Opportunity for PWS is Substantial.
While the lack of approved treatments for PWS alone make it difficult to assess the market, sales of Pfizer’s (NYSE: PFE)
Genotrop in (somatropin) can provide some insight despite being indicate for PWS, in addition to, growth failure due to growth hormone deficiency(GHD),Turner syndrome,idiopathic short stature,and small for gestational age.This product achieved its highest revenue in 2008,with worldwide sales of approximately $900 million.While somatropin has been proven to improve growth and body composition, it does not affect the key disease component of hyperphagia and use is associated with substantial risk. Soleno is developing DCCR for the treatment of PWS,to help address the unmet need of this patient population. To assess the potential of DCCR for PWS, we performed a scenario analysis, which indicates that annual sales could be in the range of $1.1 billion given a moderate price point and 50% market penetrance.
consolidation today created great buying opp
Market Cap $105 Million / Cash $150 MILLION / 1 Drug approved / Another one under review by FDA , approval likely in March = STRONG BUY AGGRESSIVEEEEEE $10 easily
sNDA Filing Accepted and PDUFA Action Date Assigned for OTIPRIO® in Acute Otitis Externa (AOE): In July, Otonomy announced that its Supplemental New Drug Application (sNDA) for the approval of OTIPRIO (ciprofloxacin otic suspension) as a treatment for patients with AOE was accepted for filing by the U.S. Food and Drug Administration (FDA) and assigned a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review by the FDA.
looks like another green day ,,love it
$1+ coming guys
new highs coming soon
this hot stock just formed a few months ago may be thats why its still unknown .This could really turn into one big stock in the coming months
this could be the next SRPT here
Minimum 7 Approvals expected within this year and new product launches in USA as well they expect profitability by next year according to Mr McFadden (IR) .Market Cap is laughable $24 Million- Cash $13 Million - Annual Revnue on to way to hit $16 Million anyone with a brain will quickly realize how brutally undervalued this one is .GL
Transcript of the conference last week
https://seekingalpha.com/article/4098556-sonoma-pharmaceuticals-snoa-ceo-jim-schutz-fiscal-q1-2018-results-earnings-call-transcript
Dermatology prescriptions filled for the first quarter were up 66% over last year and up 24% even versus the March 2017 quarter.
Our growing sales team now totals 30 sales reps and 5 managers. All reps have been trained, are out in the field generating prescriptions, and we are pleased to see the team hitting new weekly sales records for prescriptions filled at the pharmacy counter almost every week.
From a clinical trial perspective, we saw a publication of two studies, describing the benefits of Celacyn, our prescription scar management product, and for Sebuderm for the treatment of facial and scalp seborrheic dermatitis. Both studies are available online, in print and are great tools for our growing sales force when speaking with our customers, the dermatologists.
Our profit center businesses, which we define as our international business, acute care, animal health and our contract lab testing, are all on track for profitable growth for our full fiscal year.
And finally, our cash is healthy and we have almost no debt.
As Bob and I discuss often, it's a great time to be running this growing company with a dedicated team, all pushing towards the same goals and objectives.
Switching gears, a brief look ahead. Loyon, our skin descaling product, licensed from a German pharma company, was recently approved by the FDA and is on track for a launch in October.
You may have seen, we just received our 17th FDA approval last week for a new product and a new indication. For competitive reasons, we're not in a position to discuss this product or the timing for the launch. But suffice it to say that we should have an active nine months ahead with the FDA.
In Brazil, the regulatory equivalent of the FDA, which is Anvisa, asked us for more information on our pending dermatology products in the June timeframe. We've already answered their questions and provided all requested information.
We now expect up to seven new dermatology product approvals – and I'm going to repeat that, not launches, but approvals – specifically for the Brazilian dermatology market this fall.
As you'll no doubt remember, Brazil has become the world's third-largest market for beauty products after the US and Japan. And in plastic surgery and in dermatology procedures, Brazil is now the world's second-biggest market after the US.
Additionally, we have a handful of new approvals pending in the Middle East and in China. And we look forward to providing you with more information on our international dermatology growth soon.
So, in closing, we had a strong quarter due to our team's focus on our execution. We are well positioned for the remainder of this year and beyond.
SLNO(Market-Cap $19 M) Potential Blockbuster Drug in Phase 3 .. I really really like this one especially because of its dirt low valuation of $19 Million and the huge potential of the Drug .This is a strong buy aggressive at this ridiculous price .Fair Value for a such company should be $4-6 and much higher with positive Phase 3 results which expected by end 2018 .GL
Initiating Coverage June 26, 2017
http://www.lifescicapital.com/wp-content/uploads/Soleno.pdf
•Company expects to initiate pivotal Phase III clinical trial by year-end 2017; will take approximately 9-12 months to complete
Market Opportunity for PWS is Substantial.
While the lack of approved treatments for PWS alone make it difficult to assess the market, sales of Pfizer’s (NYSE: PFE)
Genotrop in (somatropin) can provide some insight despite being indicate for PWS, in addition to, growth failure due to growth hormone deficiency(GHD),Turner syndrome,idiopathic short stature,and small for gestational age.This product achieved its highest revenue in 2008,with worldwide sales of approximately $900 million.While somatropin has been proven to improve growth and body composition, it does not affect the key disease component of hyperphagia and use is associated with substantial risk. Soleno is developing DCCR for the treatment of PWS,to help address the unmet need of this patient population. To assess the potential of DCCR for PWS, we performed a scenario analysis, which indicates that annual sales could be in the range of $1.1 billion given a moderate price point and 50% market penetrance.
Very Strong Insider & institutional Ownership:
Vivo Ventures LLC 16 012 808
Forward Ventures Services LLC 7 251 728
Technology Partners 7 050 691
Aspire Capital Partners LLC 2 791 666
Ernest Mario, PhD 1 844 328
Oppenheim Asset Management Services SARL 574 853
Medical Strategy GmbH 503 305
Palo Alto Investors LLC 423 738
Sabby Capital LLC 233 938
The Bollard Group LLC 192 217
Some insider buying
http://openinsider.com/search?q=snoa
SNOA (MC $23 M)(Cash $13 M) Shares Out 4.3 M / Lots of Marketed Products some of them are in early launch phase plus additional Product launches expected within 6 months / Revenue close to hit $16 million/Profitability expected in 2018 . This undiscovered and revenue generating company is one if not the cheapest pharma you can get at this time .This Stock looking fantastic on all fronts it has a terrible low valuation of $23 Million is well financed with around $13 million and has a ultra low O/S of only 4.3 million .
This low float stock has the potential to hit $50 per share (~ $215 Million) within 12-18 months and even then the valuation would be still low . GL
Sonoma Pharma (Nasdaq: SNOA)
Market Cap: 22.1 Million
Cash: $12.6 Million
Price: $5.15
Shares Out : 4.3 Million
Presentation
http://ir.sonomapharma.com/common/download/download.cfm?companyid=ocls&fileid=945547&filekey=F57B6874-6CD1-4205-A160-8E08BBB7A928&filename=SonomaPharma_Investor_presentation_13June2017.pdf
Fact Sheet
http://files.shareholder.com/downloads/OCLS/4977255852x0x231236/39d834a3-8462-40ee-8650-e0945b6facd5/Sonoma_Fact_Sheet.pdf
Driving to commercial EBITDAS breakeven, without dilution
Grow current product portfolio with all sales people
•Alevicyn HydroGel, Dermal Spray & Spray Gel for atopic dermatitis & dermal procedures •Celacyn for scar treatment
•Mondoxyne for severe acne –launched late 2015
•Ceramax for skin repair in atopic dermatitis–launched in April 2016
•SebuDerm for seborrhea dermatitis –launched in November 2016
Launch 3 New Products –our product pipeline –one every other quarter
•Launching Loyon–Fall 2017
•Ceramax in foam and gel forms –Q4 2017 & Q1 2018
Launch and Grow New and Current Products: During fiscal year 2017, we launched four new dermatology products, including SebuDerm™, Ceramax™, Lasercyn™ Gel and Lasercyn™ Dermal Spray, bringing us to a total of eight dermatology products for the treatment of atopic and seborrheic dermatitis, scar management, surgical procedures, severe acne and “state of the art” skin repair technology. We also obtained three new FDA clearances, now totaling 16 overall. Our strong intellectual property portfolio consists of 63 issued patents and 33 patent applications pending.
We plan to launch our new FDA approved product Loyon® (a skin descaler currently marketed in Europe) in the upcoming months and have a strong product pipeline of several product line improvements, including a line extension of Ceramax™. All in all, we believe this could possibly be our best product line of new FDA approved dermatology and skincare products yet, and we believe our innovation plan will help lead us to profitability.
Regulatory Approvals and Clearances
To date, we have obtained 17 clearances from the U.S. Food and Drug Administration, or FDA, that permit us to sell our products as medical devices for Section 510(k) of the Federal Food, Drug and Cosmetic Act in the United States.
Outside the United Sates, we sell products for dermatological and advanced tissue care with a European Conformity marking (known as Conformité Européenne or CE) covering 25 of our products, and various approvals in Central America, China, Southeast Asia, and the Middle East.
Positive Phase 3 Results ---
AcelRx Pharmaceuticals Reports Successful Outcome of ZALVISO Phase 3
IAP312 Study on Device Functionality
https://finance.yahoo.com/news/acelrx-pharmaceuticals-reports-successful-outcome-110000759.html
Good news indeed , this low float stock could hit new highs before FDA decision which is expected in Q2 2018 if everything goes well .A great stock to own for the coming weeks and mnonths especially because of its very low valuation of $21 million .
and uo she goes again
need to break the ma(200) at 2.46 then it could run to $3++ quickly