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To the point of this post, I personally wish narcan was outlawed and the "epidemic" would just burn itself out in no time at all. And I couldn't care less about the "people" (junkies) who abuse drugs like these.
When you learn to use punctuation correctly come back and talk. If you could comprehend what I was saying your 2 posts are moot.
Who said a buyout by December? That is in a week from friday. I doubt anything substantial will happen before the end of the year. Not sure why you added a timeline to what I said, I am merely saying, if its an option of going at everything alone or taking a high premium buyout, they should take the buyout. In my opinion that would be best for not only Management but also shareholders, especially with everything going on to destroy the opioid market. Having this strong of a drug in an industry that is constantly being attacked it would be unwise to string this along for a long period (years), otherwise we could lose everything if major restrictions/restructuring aka regulation changes occur. It's great FDA gave us approval but it doesnt mean our industry cant have massive regulation changes that would ruin us. We could have a bright future, but it could also all disappear in an instant. Huge risks vs the possibility of huge rewards. That is all I'm trying to say.
what would you like them to do if December comes and no offers to buy then there would be little time to finance going it alone plus you would have shorts using the stock like a blow up doll or they could not go it alone with a highly sought after product that is needed like right now but only to be boxed in to fork out large sums of money for someone else to do the job. They are do it exactly right. They are organized and that alone is leverage in a potential buy out if there even is one
That tells me they likely only care about themselves and not shareholders, but only time will tell. Personally I hope they get a buyout offer they cant refuse due to the attractiveness. These otc plays that try to keep everything inhouse seem to always screw over the shareholder while they get rich.
They decided to distribute in house instead hiring a national distribution company and are also looking into a distribution partner in Europe. As you can see, has not reflected well in the short term but, imo, the revs will be much higher without the costs of hiring a distributor and better for the shareholder when the do put the product out.
Some nice movement occurring
A little scary nothing seems to be happening here anymore. You would think with our powerful new drug we would be really moving. My guess is we are waiting for a buyout, just hope it has a massive premium attached.
early trades could be a turning point. Just below the 200 day ma - it has bounced off before so this is an important chart moment. Good luck longs! BTW, where did Clay trader posts go? His chart analysis is helpful and I don't see his past posts.
LOL maybe they will pay me to take shares, that might be the only way I can average this pig
Pretty soon you won't have to pay
you paid 5 bucks for your shares, right?
Oh yipee more dilution, just love when a "CEO" screws his shareholders.
DILUTION is always a great idea to death spiral a company. now why would someone want to buy the new issue at 3.15 when we can buy today at 2.80 and the way it is going wait until next week and pick it up for 2 bills
Today at the conference around 1:00 I was streaming it live and ACRX CFO said just completed a capital raise they had $116 mil enough for a successful launch
$63.6 million in cash at Sept 30, 2018; est. $116 million
proforma Sept 30 (Q4 ATM proceeds and equity offering)
He was the guy who also added 5000 shrs yesterday he now has a modest 47,000 shrs
The real question is if the dilution is finally over.
AcelRx Pharmaceuticals to Present at the 17th Annual ASRA Pain Medicine Meeting
PR NEWSWIRE 4:05 PM ET 11/14/2018
Symbol Last Price Change
ACRX 3 -0.16 (-5.06%)
QUOTES AS OF 04:00:00 PM ET 11/14/2018
REDWOOD CITY, Calif. , Nov. 14, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc.(ACRX) , a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the use in medically supervised settings, today announced an upcoming presentation at the 17th Annual Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine (ASRA). The presentation is part of the Emerging Technology Moderated Poster session. ASRA's Annual Pain Medicine Meeting will take place November 15-17, 2018 in San Antonio, TX.
This presentation analyzes postoperative analgesic drug dosing in a multi-center, randomized open-label, parallel-group study comparing IV morphine sulfate to sufentanil sublingual tablets (SST). Over the first five hours, patient dosing in each treatment arm suggests that a single 15 mcg or 30 mcg tablet has the equivalent analgesic effect to approximately 2.5 mg or 5 mg of IV morphine, respectively.
Details on the presentation are as follows:
Title:
IV Morphine Equivalence of the Sufentanil Sublingual Tablet Based on Dosing Analyses from a Phase 3 Active Comparator Trial (Moderated Poster #6012)
Authors:
Timothy Melson, MD of Helen Keller Hospital; Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Jacob Hutchins, MD of University of Minnesota; and Pamela P. Palmer, MD, PhD and Karen DiDonato, MSN, RN of AcelRx Pharmaceuticals(ACRX).
Date/Time:
Friday, November 16, 2018; 10:30am-12:15pm CT
Location:
Session MP-06a, Cibolo 4, JW Marriott San Antonio Hill Country
The American Society of Regional Anesthesia and Pain Medicine (ASRA) is one of the largest subspecialty medical societies in anesthesiology with nearly 5,000 members in 66 countries on 6 continents. For more information, please visit www.asra.com.
About DSUVIA™ (sufentanil sublingual tablet, 30 mcg)
DSUVIA™, known as DZUVEO™ outside the United States, approved by the FDA in November 2018, is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018. For more information, please visit www.DSUVIA.com.
LIMITATIONS OF USE
Not for home use or for use in children. Discontinue treatment with DSUVIA before patients leave the certified medically supervised healthcare setting. Not for use for more than 72 hours. The use of DSUVIA beyond 72 hours has not been studied. Only to be administered by a healthcare provider.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DSUVIA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia.
The Full Prescribing Information for DSUVIA contains the following Boxed Warning:
WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM: LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE AND MISUSE; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Accidental Exposure and DSUVIA REMS Program:
Accidental exposure to or ingestion of DSUVIA, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, DSUVIA is available only through a restricted program called the DSUVIA REMS Program. DSUVIA must only be dispensed to patients in a certified medically supervised healthcare setting. Discontinue use of DSUVIA prior to discharge or transfer from the certified medically supervised setting.
Life-Threatening Respiratory Depression :
Serious, life-threatening, or fatal respiratory depression may occur with the use of DSUVIA. Monitor for respiratory depression, especially during initiation of DSUVIA.
Addiction, Abuse, and Misuse :
DSUVIA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing DSUVIA, and monitor all patients regularly for the development of these behaviors or conditions.
Cytochrome P450 3A4 Interaction :
The concomitant use of DSUVIA with cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration. Monitor patients receiving DSUVIA and any CYP3A4 inhibitor or inducer.
Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants:
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.
IMPORTANT SAFETY INFORMATION
DSUVIA is contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and known hypersensitivity to sufentanil or components of DSUVIA.
DSUVIA contains sufentanil, a Schedule II controlled substance. As an opioid, DSUVIA exposes users to the risks of addiction, abuse, and misuse. Potential serious adverse events caused by opioids include addiction, abuse, and misuse, life-threatening respiratory depression, neonatal withdrawal syndrome, risks of concomitant use or discontinuation of cytochrome P450 3A4 inhibitors and inducers, risks from concomitant use with benzodiazepines or other CNS depressants, risk of life threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients, adrenal insufficiency, severe hypotension, risks of use in patients with increased intracranial pressure or impaired consciousness, gastrointestinal disorders and seizure disorders. DSUVIA should be used with caution in patients with severe liver or kidney impairment.
For Important Safety Information including full prescribing information, visit: www.DSUVIA.com.
Clinical and Rehabilitative Medicine Research Program (CRMRP)
DSUVIA was funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries. In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).
About AcelRx Pharmaceuticals, Inc.(ACRX)
AcelRx Pharmaceuticals, Inc. (ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., DSUVIA (sufentanil sublingual tablet, 30 mcg), known as DZUVEO in Europe, indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.
For additional information about AcelRx, please visit www.acelrx.com.
AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)
Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-to-present-at-the-17th-annual-asra-pain-medicine-meeting-300750664.html
SOURCE AcelRx Pharmaceuticals, Inc.(ACRX)
Thanks Lenard, interesting point. I'll have to read the conference, I didn't see it. Thanks again.
The conference was interesting today and this didn't get hit today like other bio's did, I thought this one would have tested the mid 2's, maybe it still will but they are ready to go it alone
The market has obviously been ravaged. It will continue until the market improves or we spike with the first contracts.
Looks like the pps today is a reflection of not quite the demand for the offering even at the already low offering price, should bounce after they flood the market
Dilution should end tomorrow. Not surprising he bought now in the last hr of trading before the last day.
A form 4 dropped...someone thinking prices below the offering is a “buy”
https://www.sec.gov/Archives/edgar/data/1427925/000120919118058155/xslF345X03/doc4.xml
Not that there ever is any consistency in these things but I always am looking for a pop to exit and then return for the long term
There are huge uncertainties investing in any small biotech. If you are a trader that was hoping for a big pop on FDA approval the price action was a huge bummer. I am long and have some 2019 calls also, but I too thought there would be a pop on approval and picked up some Nov. calls. I suspect there is about a 98% chance they worthless. That sucks, but I still feel good about my long term investment.
For the long term, in the short term maybe it will reach highs, but for now, everything else partnerships, BO, etc, is all talk who knows when that will happen? December? 2019? 2020? 2021? never?
I see it exactly as you do, I'm holding for long term 1QTR.
There has been obvious coordinated manipulation by shorts since FDA approval. If full blown max potential sales were a 100% certainty it would be trading far higher and this would not be a investment with tremendous upside from here. If you have done your DD and don't think the company can successfully transition to commercialization, with or without a partner, cut your losses. I happen to beleive the capital raise is partially in an effort to give them an upper hand in partnership negotiations or even a BO. I think overseas partnership is a certainty and that partner will hit the ground running with an established sales force and distribution channels so sales there will likely ramp up faster than in the US. They now have the world wide gold standard approval, the FDA. They should also have the near term large sale to the US DOD. How could that sale not be great for marketing world wide.
Potential also can mean fail. Consider the article came out the night before the offering, and the article put out after what amounted to the pps drifting downward. For such potential to be positive the stock has yet to show this except the fact it is trading above the offering price
opening with some volume in the right direction.
Yes I am. A biotech transitioning from development stage to commercialization should still be largely valued on potential not just actual sales.
"Hopes are..." ---I got it already read it so I take it you're more optimistic than savagessmaster
There are several articles at SA on ACRX, which one, or did you just want to play checkers?
FDA approved November 2nd. AcelRx now $100 million dollars CASH, launching DSUVIA $1.1 BILLION Revenue estimated in the United States... DZUVEO European approved 5 months ago, with estimated EU Revenue $700/800 million dollars...
Patience people!!! If you want to gamble go to Las Vegas. We have huge potential here..just matter of time...
I suggest reading the SA article: Hopes Are High For AcelRx After Dsuvia Approval - Will Price Follow? I think it has a more educated and well thought through price estimate.
And besides that vague observation, maybe you could offer your numbers
Wow. Not sure where to begin with this post. You think the company will hit 50% of max potential sales in its first year on the market? Not going to happen. You think a company's market cap is based simply on its current year gross sales divided by number of outstanding shares, not taking into account profit margin, PE ratio, etc? I say again, Wow!
Current market cap is 200 million. The new drug is expected to peak at around 1 Billion in annual sales. If 2019 brings in half that not to mention there other drugs on the market lets just say 500 million then the PPS even if you add all the new shares to the outstanding for a total I am guessing around 80 million, this should go to around $6-8 per share very soon but on one condition, the dam dilution stops. Any more shares get dumped into the float it will never make it. Hopefully the current offering is the end of it and the price has already been adjusted for that on Friday.
At 12.8M in volume, even after the dilution - which may not end for a little while, the price went up. I don't think the DoD nor the management has any plans to stop now. They have too much invested and the way forward is clear. This most likely will see high volatility well into 1Q 2019 as investors take profits and reinvest when contracts come in. Milestones and catalysts will keep this moving along at a churn. My own target is well above $5, but I've no real idea how high this might go, so I'll play it by the week as it moves.
They seem to be doing what they should and they have spent a lot of time developing such a product which the FDA sees as an acceptable alternative even with the opioid controversy. Having said that, I too hope for the best, but I also find myself struggling with the unknown seen by the "what if's" and the "maybe they" etc. And as far as price targets go, they just give investors a sense of price direction at best. Analysts are full of shit and are lapdogs and take advantage of retail investors because of the unknown
analysts still project high price targets, even after the share sale. Maybe management knows what they are doing, maybe buyout was lowball and they will be more successful developing the market themselves, maybe they even have a big contract coming from DOD. You don't know what management might have going - what if they are actually competent? What do we know? hoping for the best.
I soaked up some. I'm done now though, need this to hit $5 by January so I can cash my Calls in.
Sparky Sparky
You said below 3 bucks by EOD, make up your mind, but you make it up as you go along
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Market Cap: $108 Million
Cash: $72 Million
Price: $2.40
Shares Out: 45.3 Million
Upcoming Major Milestones
Zalviso Phase 3 Results in July 2017
DSUVIA PDUFA Date October 12, 2017
Zalsviso NDA Resubmission in Q4 2017
DSUVIA CHMP Opinion in 1H 2018 (EU Approval )
Presentation June 2017
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjczNjExfENoaWxkSUQ9MzgxNTY1fFR5cGU9MQ==&t=1
Jefferies Sees Strong Upside in AcelRx Pharmaceuticals’ Shares and Set a $7 Price Target
https://finance.yahoo.com/news/jefferies-sees-strong-upside-acelrx-145225845.html
Biotech Catalyst Play: AcelRx Pharmaceuticals Inc (NASDAQ:ACRX)...
https://insiderfinancial.com/biotech-catalyst-play-acelrx-pharmaceuticals-inc-nasdaqacrx
While Zalviso is our near-term catalyst, the DSUVIA decision probably holds more weight from a valuation perspective. Why? Because peak sales for this one are estimated at a little over $1.1 billion in the US alone. If FDA gives a green light for commercialization to the asset, therefore, the company could have a blockbuster drug on its hands. Combine that with the close to $400 million in revenues potential from Zalviso, and AcelRx could very justifiably become a multibillion-dollar biotech company before the end of the decade.
https://finviz.com/quote.ashx?t=acrx&ty=c&ta=1&p=d
Shs Outstand | 119.10M |
Shs Float | 116.83M |
Short Float | 13.47% |
Insider Own | 2.00% |
Inst Own | 34.80% |
Inst Trans | 43.60% |
Inst Trans | 43.60% |
ROE | 66.50% |
ROI | 120.80% |
Employees | 54 |
Forward P/E | 16.13 |
Recom | 1.70 |
52W Range | 1.01 - 2.94 |
minor resistance $1.70 [-chart]finviz.com/chart.ashx?t=acrx&ty=c&ta=1&p=d&s=l[/chart]
02-07-2021
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