Mallinckrodt Plc (MNKT)

[ctcollins]

That is not Mallinckrodt..... So I don't know why you're asking this board.

[ctcollins]

Nov. 19, 2019 /PRNewswire/ --  Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, will present on Tuesday, Dec. 3, 2019 , at the Piper Jaffray Annual Healthcare Conference at the Lotte New York Palace, 455 Madison Ave , New York. 

Mark Trudeau , President and Chief Executive Officer, and Steven Romano , M.D., Executive Vice President and Chief Scientific Officer, will represent the company in a fireside chat at 8:30 a.m. Eastern.  
Individuals who cannot attend the meeting in person can find webcast information at: http://www.mallinckrodt.com/investors. A replay will also be available following the meeting.

ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt , visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

[whytestocks]

$MNK bulls and bears Mallinckrodt Plc Nyse Mnk Short Squeeze

[BBANBOB]

ANY WORD ON THIS YET??????????????????????????


https://www.sec.gov/Archives/edgar/data/1580149/000152013819000418/bivi-20191101_s1a7.htm

WHO WILL PREVAIL ? Next week, Nov. 14, 2019 <<< FINAL DECISION

[BBANBOB]

We should be getting a filing tonight I would think!

[BBANBOB]

ANY WORD ON THIS YET??????????????????????????


https://www.sec.gov/Archives/edgar/data/1580149/000152013819000418/bivi-20191101_s1a7.htm

WHO WILL PREVAIL ? Next week, Nov. 14, 2019 <<< FINAL DECISION

[ctcollins]

Bio-Tech Stocks in focus

Mallinckrodt Reports Positive Efficacy Data For Acthar Gel

Mallinckrodt PLC (NYSE:MNK) announced Phase 4 data on patient-reported outcomes for its Acthar Gel (repository corticotrophin injection), which showed improved disease measures that impact rheumatoid arthritis patients with persistently active disease, as early as Week 4, and resulted in clinically meaningful improvements in PROs. The data was presented at the American College of Rheumatology/Association of Rheumatology Professionals 2019 annual meeting.

The stock rose 1.79% to $2.85 in after-hours trading.

[ctcollins]

November 12, 2019 04:32 PM ET (BZ Newswire) -- Biotech

New analysis from Phase 4 study in RA showed that statistically significant improvement from baseline in patient-reported outcomes for pain, fatigue, physical functioning and work-related impairment was associated with Acthar Gel treatment - -- Results from an exploratory analysis showed bone and cartilage biomarker levels in patients treated with Acthar Gel were largely stable and markers of bone degeneration remained stable.

STAINES-UPON-THAMES, United Kingdom, Nov. 12, 2019 /PRNewswire/

Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced data on patient-reported outcomes (PROs) showing Acthar® Gel (repository corticotropin injection) improved disease measures that impact rheumatoid arthritis (RA) patients with persistently active disease, as well as new data from an exploratory analysis. The data originate from new analyses from Mallinckrodt's Phase 4 study of Acthar Gel in RA patients with persistently active disease and was recently presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held Nov. 8-13 in Atlanta.

[ctcollins]

November 12, 2019 04:32 PM ET (BZ Newswire) -- Biotech

New analysis from Phase 4 study in RA showed that statistically significant improvement from baseline in patient-reported outcomes for pain, fatigue, physical functioning and work-related impairment was associated with Acthar Gel treatment - -- Results from an exploratory analysis showed bone and cartilage biomarker levels in patients treated with Acthar Gel were largely stable and markers of bone degeneration remained stable.

STAINES-UPON-THAMES, United Kingdom, Nov. 12, 2019 /PRNewswire/

Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced data on patient-reported outcomes (PROs) showing Acthar® Gel (repository corticotropin injection) improved disease measures that impact rheumatoid arthritis (RA) patients with persistently active disease, as well as new data from an exploratory analysis. The data originate from new analyses from Mallinckrodt's Phase 4 study of Acthar Gel in RA patients with persistently active disease and was recently presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held Nov. 8-13 in Atlanta.

[ctcollins]

November 12, 2019 04:32 PM ET (BZ Newswire) -- Biotech

New analysis from Phase 4 study in RA showed that statistically significant improvement from baseline in patient-reported outcomes for pain, fatigue, physical functioning and work-related impairment was associated with Acthar Gel treatment - -- Results from an exploratory analysis showed bone and cartilage biomarker levels in patients treated with Acthar Gel were largely stable and markers of bone degeneration remained stable.

STAINES-UPON-THAMES, United Kingdom, Nov. 12, 2019 /PRNewswire/

Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced data on patient-reported outcomes (PROs) showing Acthar® Gel (repository corticotropin injection) improved disease measures that impact rheumatoid arthritis (RA) patients with persistently active disease, as well as new data from an exploratory analysis. The data originate from new analyses from Mallinckrodt's Phase 4 study of Acthar Gel in RA patients with persistently active disease and was recently presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held Nov. 8-13 in Atlanta.

[ctcollins]

Mallinckrodt Highlights Presentation Of Phase 3 Results From CONFIRM Study Of Terlipressin For HRS-1; Study Met Primary Endpoint

Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced results from its pivotal Phase 3 CONFIRM study to assess the efficacy and safety of its investigational agent terlipressin in adults with hepatorenal syndrome type 1 (HRS-1). HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1 Results were reported during a late-breaking abstract presentation today at The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), in Boston. The CONFIRM abstract was also selected by AASLD for inclusion in its prestigious "Best of the Liver Meeting" educational program in the portal hypertension/cirrhosis category.

In the 35-month study period, 300 patients from the U.S. (89 percent) and Canada (11 percent) participated in the largest-ever prospective, multi-center randomized controlled clinical trial in HRS-1. Patients in the study were critically ill, as indicated by assessments of their liver and kidney function at the start of the trial. Patients in the trial had a mean Model for End-Stage Liver Disease (MELD) score of 33; a mean serum creatinine (SCr) level of 3.5 mg/dL; and 61 percent were categorized as Child-Pugh Class C.2

The study met its primary endpoint of Verified HRS Reversal (VHRSR), which is defined as renal function improvement, avoidance of dialysis and short-term survival. 29.1 percent (58/199) of patients administered terlipressin plus albumin achieved Verified HRS Reversal versus 15.8 percent (16/101) on placebo plus albumin (p=0.012). In order to achieve Verified HRS Reversal, patients had to have two consecutive SCr values ≤1.5 mg/dL, at least two hours apart by day 14 or hospital discharge, and be alive without intervening renal replacement therapy (RRT) for at least 10 days following discharge or treatment.2 "HRS-1 is a rapidly progressing and often fatal disease that is extremely difficult to diagnose and treat, and many patients don't live beyond a few weeks without treatment. The results from the CONFIRM trial are very encouraging, and show terlipressin, if approved, has the potential to reverse the course of HRS-1 as measured by renal function improvement, avoidance of dialysis and short-term survival," said presenting author Florence Wong, MBBS, MD, FRACP, FRCPC, hepatologist at Toronto General Hospital, and professor of Medicine at the University of Toronto. "These results provide important information that may help the healthcare community better manage this critically ill and underserved patient population."

HRS-1 has a median survival time of less than two weeks and greater than 80 percent mortality within three months if left untreated.3,4 At present, there are no approved drug therapies for HRS-1 in the U.S. or Canada.5 HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.6,7 Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the U.S. FDA or Health Canada. The company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the first half of 2020.

"We are grateful to all the patients and investigators who participated in the CONFIRM trial and greatly encouraged by the positive results, which demonstrated that terlipressin may have a potential impact on the progressively worsening kidney function that is the hallmark of HRS-1," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "Today marks the culmination of a long clinical development journey led by our passionate, dedicated clinical development team. The results from this largest-ever prospective phase 3 clinical trial in HRS-1 provide meaningful insight into the management of HRS-1 in clinical practice."
CONFIRM Study Key Findings2
The study met its primary endpoint of Verified HRS Reversal, defined as two consecutive SCr values ≤1.5 mg/dL, at least two hours apart by day 14 or discharge, with subjects alive without RRT for at least 10 days after the second SCr ≤1.5 mg/dL. 29.1 percent (n=58) of patients treated with terlipressin plus albumin compared to 15.8 percent (n=16) of patients treated with placebo plus albumin (p=0.012) achieved Verified HRS Reversal.

The four pre-specified secondary endpoints of the study were:
HRS reversal: 36.2 percent (n=72) of patients in the terlipressin group demonstrated HRS reversal, defined as the percentage of participants with a SCr value no more than 1.5 mg/dL by day 14 or discharge versus 16.8 percent (n=17) on placebo (p<0.001). Durability of/maintaining HRS reversal: 31.7 percent of patients receiving terlipressin (n=63) maintained HRS reversal without RRT/dialysis up to day 30 versus 15.8 percent (n=16) in the placebo group (P<0.003).HRS reversal in the systemic inflammatory response syndrome (SIRS) subgroup: 33.3 percent (28/84) of patients with SIRS in the terlipressin arm achieved Verified HRS reversal versus 6.3 percent (3/48) in the placebo arm (p<0.001).
Verified HRS Reversal without HRS recurrence by day 30: 24.1 percent (n=48) of patients on terlipressin and 15.8 percent (n=16) of patients in the placebo group (p=0.092) achieved Verified HRS Reversal without recurrence by day 30.

Adverse events (AEs) were similar in both groups. Serious AEs were reported in 65 percent (n=130) of subjects in the terlipressin group and 60.6 percent (n=60) in the placebo group. The most commonly reported serious AEs included respiratory failure, which occurred in 10 percent of the terlipressin group and 3 percent of the placebo group; and abdominal pain, which occurred in 5 percent of the terlipressin group and 1 percent of the placebo group. The most commonly reported AEs included abdominal pain, which occurred in 19.5 percent of the terlipressin group and 6.1 percent of the placebo group; and nausea, which occurred in 16 percent of the terlipressin group and 10.1 percent of the placebo group. Ischemia-associated AEs occurred in 4.5 percent of the terlipressin group and 0 percent in the placebo group. No new or unexpected AEs were reported.

[ctcollins]

Mallinckrodt to Pay Executive Bonuses as Opioid Cases Loom

Mallinckrodt plans to pay more than $4.2 million in bonuses to retain top executives, as the drugmaker looks to avoid bankruptcy and settle more than 2,500 state and local government lawsuits over its handling of opioid painkillers.

The St. Louis-based drug distributor said in a Nov. 5 securities filing that it, or one of its units, may have to restructure the company’s “obligations in a bankruptcy proceeding” if a global deal can’t be reached to wipe out all opioid liability.

In a separate filing the same day, Mallinckrodt said it agreed to pay retention bonuses to its top executives, including Chief Executive Officer Mark Trudeau, who stands to get more than $1.5 million. The company’s chief financial, legal and scientific officers will also get extra compensation to remain in their jobs.

Mallinckrodt shares fell 8.8% to $2.76 at 10:13 a.m. in New York, falling sharply for the third consecutive trading session. The company’s bonds were among the top decliners in the U.S. high-yield market on Thursday, according to Trace bond-trading data. Mallinckrodt’s notes due 2023 and 2025 both fell more than 4 and 5 cents on the dollar to trade around 24 cents.

Mallinckrodt, along with fellow drug distributors McKesson Corp. and Cardinal Health Inc., and opioid makers Johnson & Johnson and Teva Pharmaceutical Industries Ltd., are talking with state attorneys generals and the municipalities’ lawyers about a global settlement. Some of those companies have floated a deal valued at almost $50 billion.

“It’s unusual for a company to pay those bonuses prior to a Chapter 11 filing,” said Chuck Tatelbaum, a Florida-based bankruptcy attorney who has worked on dozens of reorganizations. “I see this as some real message-sending to the local governments that they better get a deal done or the thing will land in bankruptcy court.”

The retention payments were determined to be appropriate by a committee of the board of directors, Mallinckrodt said in a statement. The company declined to comment on whether the bonuses were meant to keep the executives around to help navigate a potential bankruptcy.

“We are navigating a challenging market environment and working to achieve a number of key objectives, including addressing near-term debt maturities, resolving opioid claims and pursuing a separation of the specialty generics business,” the company said in a statement.

Teva is offering $23 billion in donated opioid-treatment drugs plus $250 million in cash while J&J has said it’s willing to kick in $4 billion in cash. Another $18 billion in cash would come from McKesson, Cardinal Health and AmerisourceBergen Corp. Mallinckrodt hasn’t made public what it’s offering to resolve the cases.

Many cities and counties -- along with some states -- have turned their noses up at the current offer, saying it isn’t enough to address the fallout from opioid addictions and overdoses across the U.S.

Local governments in hard-hit states including Ohio, West Virginia and Kentucky have accused opioid makers, distributors and pharmacy chains of understating the risks of prescription opioids, overstating their benefits, failing to halt suspiciously large shipments, and ignoring red flags about repeated retail sales.

“We are aware of Mallinckrodt’s risk of bankruptcy and we are willing to discuss a reasonable resolution with them,” Joe Rice, one of the lawyers leading the cities’ and counties’ cases, said Wednesday. He’s also one of the leaders in the settlement talks.

Mallinckrodt has made no secret that its looming opioid liability has the distributor feeling the financial heat. The company faces a $5 billion debt load and said in securities filings that it may be forced to pay “material amounts” as part of any opioid settlement.

Some analysts have estimated it could take as much as $150 billion in total to wipe out all liability for companies that made, sold or distributed opioids.

In September, Mallinckrodt hired restructuring experts from AlixPartners LLP. Earlier this week, it sought to refinance some debt by exchanging bonds for new securities at a discount. If creditors sign on, the company could chop its debt by more than $800 million.

To safeguard the company’s top management, Mallinckrodt directors agreed last month to pay bonuses to keep executives around for at least 18 months, according to the securities filings.

Besides Trudeau, the board agreed to give a $900,000 bonus to Mark Casey, Mallinckrodt’s chief legal officer, $930,000 to Steven Romano, the firm’s chief scientific officer and $825,000 to Chief Financial Officer Bryan Reasons. The bonuses would have to be repaid if any of the executives leaves or is fired over the next year and a half.

The case is In Re National Prescription Opioid Litigation, 17-md-2804, U.S. District Court, Northern District of Ohio (Cleveland).

[BBANBOB]

Shorts are playing with FIRE HERE Lit Dynamite here.

This thing has VW/PORSCHE written all over it

Also can someone EXPLAIN to me how institutionals can own 126% of a company

[ctcollins]

11:25 AM EST, 11/07/2019 (MT Newswires) -- Mallinckrodt (MNK), a maker of specialty pharmaceutical products, said Thursday that clinical results showed that multiple sclerosis relapse patients taking Acthar gel had a higher relapse resolution rate versus those taking intravenous or plasmapheresis treatment.
Acthar gel is currently approved by the US Food and Drug Administration for the treatment of acute exacerbations of multiple sclerosis in adult patients.

[ctcollins]

STAINES-UPON-THAMES, United Kingdom , Nov. 8, 2019 /PRNewswire/ -- Mallinckrodt plc  (NYSE: MNK), a global biopharmaceutical company, will present at the Jefferies London Healthcare Conference in London on Wednesday, Nov. 20, 2019 .

Bryan Reasons , Executive Vice President and Chief Financial Officer, will represent the company in a fireside chat at 8:40 a.m. GMT .  
Individuals who cannot attend the meeting in person can find webcast information at: http://www.mallinckrodt.com/investors. A replay will also be available following the meeting.
ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt , visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

[ClayTrader]

* * $MNK Video Chart 11-07-19 * *

Link to Video - click here to watch the technical chart video

[ctcollins]

Mallinckrodt Highlights Publication Of Data On Treatment Effectiveness Of Acthar Gel For Resolution Of Multiple Sclerosis Relapse In US Health Plan Population
7:16 am ET November 7, 2019 (Benzinga) Print
Mallinckrodt plc (NYSE:MNK), a global biopharmaceutical company, today announced the publication of "Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a U.S. Health Plan Population" in an electronic publication posted in advance of print publication in the peer-reviewed journal Neurology and Therapy. Results from the analysis showed that multiple sclerosis (MS) relapse patients taking Acthar® Gel (repository corticotropin injection) had a higher relapse resolution rate than those taking intravenous immunoglobulin (IVIG) or plasmapheresis (PMP) treatment.

MS is a chronic, degenerative disease that can cause numerous impairments including fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes1, and some people with MS experience relapses while on standard disease-modifying therapies.2
Acthar Gel is U.S. Food and Drug Administration (FDA)-approved for the treatment of acute exacerbations of MS in adults. Controlled clinical trials have shown Acthar Gel to be effective in speeding the resolution of acute exacerbations of MS. However, there is no evidence that it affects the ultimate outcome or natural history of the disease.3 Please see Important Safety Information for Acthar Gel below.
"The management of MS relapse is an ongoing challenge, in particular for those patients who need additional treatment options after first-line agents such as corticosteroids," said George Wan, Ph.D., Vice President and Global Head of Health Economics and Outcomes Research at Mallinckrodt. "We are committed to working toward a better understanding of the potential clinical and health economic outcomes associated with Acthar Gel and other late-line treatments for MS relapse to help guide clinical practice and potentially improve outcomes for patients. In addition, we look forward to the results of Mallinckrodt's ongoing, randomized, double-blind, placebo-controlled OPTIONS study, which we anticipate will provide data on some of the more difficult-to-treat MS patients in the future."
"Treatment Effectiveness for Resolution of Multiple Sclerosis Relapse in a US Health Plan Population" evaluated the rate of MS relapse occurrence, frequency of use of MS relapse treatments including corticosteroids, and relapse treatment effectiveness (or relapse resolution rates) for corticosteroid treatment alternatives – Acthar Gel, IVIG, and PMP. No minimum health plan enrollment was required. The data were originally shared in a poster presentation at MSParis2017, the joint ECTRIMS-ACTRIMS meeting.4
Key findings5
9,574 patients with relapse episodes were identified with 25,162 relapse episodes [mean (SD) of 2.6 (4.0) relapse episodes per person]. The mean follow-up time per patient was 2.7± 2.1 years.
The majority of patients (74.0 percent) had <2 relapse episodes and 26.0 percent of patients experienced two or more relapse episodes per year. 36.9 percent of patients had ≥1 unresolved relapse events during the study period which required additional relapse therapy beyond the initial relapse treatment received.
The frequencies of relapse treatment alternatives used were as follows: IVIG (6.0 percent), Acthar Gel (2.2 percent), and PMP (1.5 percent).
90 percent of initial relapse events within the first relapse episodes were treated with corticosteroids
Relapse resolution rates differed by treatment. Acthar Gel had the highest proportion of patients achieving relapse resolution (96.9 percent), compared with IVIG (43.9 percent) and PMP (50.7 percent).
Methods5
A retrospective analysis of patients 18-89 years experiencing MS relapse from January 1, 2008 to June 30, 2015 was conducted using administrative claims data from Humana Inc.
MS relapse was estimated based on established claims-based methodology; and was defined as an inpatient admission or hospitalization with a principal diagnosis of MS or an outpatient visit or emergency department visit with a diagnosis of MS, followed by a medical or pharmacy claim for a relapse treatment of interest (oral corticosteroids, intravenous corticosteroids, Acthar Gel, PMP or IVIG) within 30 days.
Treatment was deemed effective in resolving the relapse (relapse resolution) if no additional relapses followed within the episode; otherwise, the relapse was considered unresolved.
A 30-day time frame was used as a marker to correlate MS relapse as either one unresolved relapse if within 30 days of the ?rst visit for relapse or a new relapse if greater than 30 days from the ?rst visit for relapse.
Limitations6
Administrative claims data are collected for reimbursement purposes, and thereby may lack important clinical detail, such as disease severity. Claims are often used in MS relapse studies. Here, a number of definitions used in prior studies were implemented in order to mitigate this limitation.
Relapses were identified based on treatment-seeking behavior using an established claims-based algorithm; treatment received/prescribed outside a healthcare visit was not addressed.
Index relapse events were first observed, which may/not be the actual first events. However, relapse resolution was based on the occurrence of subsequent relapses, not prior relapses.
Variation in treatment regimens would impact the rate of relapse resolution.
Acthar Gel and PMP/IVIG have not been studied head-to-head in any randomized, controlled clinical trials.
Not all improvements can be solely attributed to Acthar Gel.
The study assessed response to Acthar Gel and did not capture safety
© 2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved

[Trend-Setter]

PATENT CHALLENGE MNK vs. BIVI

SEC S-1/A pg.6
On April 30, 2018, we received notice that Mallinckrodt had petitioned the U.S. Patent and Trademark Office (“USPTO”) to institute an Inter Partes Review of our U.S. Patent No. 9,655,945 titled “Treatment of Ascites” (the “’945 patent”). Inter Partes Review is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more claims of a patent. Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents and printed publications.

On August 15, 2018, we submitted a Preliminary Response to the PTAB providing a rationale as to why, in our opinion, Mallinckrodt’s request to institute the IPR should not be granted. On November 14, 2018, the PTAB granted institution of the IPR challenge after determining that there was a reasonable likelihood of success in proving that at least one of our 14 claims was unpatentable. On March 7, 2019, we submitted a Patent Owner’s Response and a Patent Owner’s Contingent Motion to Amend our patent claims, and Declaration of Dr. Jaime Bosch, MD, PhD, our medical expert. On June 26 and June 28, 2019, we submitted a Patent Owner’s Reply In Support Of Its Contingent Motion To Amend Under 37 C.F.R.§ 42.121 to amend our patent claims and a Patent Sur-Reply supported by the Supplemental Declaration of Dr. Jaime Bosch to the Reply and the Opposition to Motion to Amend, filed by Petitioner Mallinckrodt, filed June 6, 2019. On July 29, 2019, we submitted a Patent Owner’s Opposition to Petitioner’s Motion to Strike. On July 17, 2019, we received from the PTAB an Order Oral Hearing in response to our request of an Oral Hearing, which was held on August 12, 2019. We are actively defending the ’945 patent and we are exploring the possibility of settlement with Mallinckrodt. However, there can be no assurance that a favorable outcome will result, or if settlement is reached that the PTAB will accept it. Although the PTAB encourages settlement, in view of public-interest considerations, the PTAB may continue the proceeding to a final written decision even if the parties settle. If the IPR is not terminated due to settlement, the PTAB is statutorily required to issue its final written decision in this case before November 14, 2019 (within one year from the date of institution).

We cannot guarantee investors that we will be successful in defending Mallinckrodt’s challenge against our patent. An unfavorable decision could reduce the scope of, or cancel, our patent rights, and allow third parties to commercialize our technology or products and compete directly with us, without payment to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to exploit our intellectual property or develop or commercialize current or future product candidates. Our ability to establish or maintain a technological or competitive advantage over our competitors and/or market entrants may be diminished because of these uncertainties. For these and other reasons, our intellectual property may not provide us with any competitive advantage.

In addition, you should note that as of June 30, 2019, no adjustments or accruals have been reflected in our financial statements related to this matter.

https://www.sec.gov/Archives/edgar/data/1580149/000152013819000418/bivi-20191101_s1a7.htm

WHO WILL PREVAIL ? Next week, Nov. 14, 2019 <<< FINAL DECISION

[BBANBOB]

Shorts being helped here LARGE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Now they best take advantage of all the help they are getting and looks like they are.

[ClayTrader]

* * $MNK Video Chart 11-06-19 * *

Link to Video - click here to watch the technical chart video

[Tbone88]

Lmao. I hear ya

[BBANBOB]

fk that i TAKE CAUSE I NEED OR
I DON'T!!!!!!!!!!!!!!

Thats is WHY I am NOW having trouble getting my meds PARTY fouls

DRINK a scotch

[Tbone88]

Oversold now. Backing the truck up. Thank you. Bottom is in.

[Tbone88]

S&p downgrades to a cc negative. Man I’ll tell ya... the writing is so damn obvious here as to how this will play out by 11/12 when they report liver results. Scumbags just busting out all tactics to buy in at a lower price. And if you’re one of them that got taken out with your weak stop sells then you have no ballz. Patience is key here. Less than 5 trading days to got to launch time.

[Tbone88]

Yes and quite frankly they make you feel good on a down CHITTY day. So why the beef USDea and trump? Yeah I lost my brother to a few 5 mg peek 5s and whiskey but it wasn’t the oxys fault. It was my Bro taking his drinking way beyond his max. Now you have many losing their scripts that actually need it... so what are they supposed to do?? Take some Kratum. Give me a fkcin break. It’s our bodies and minds and we don’t even own rights to ourselves. This country is really getting that walking on thin ice feel. Take away our drugs for pain and suffering. Next will be take away our guns for defense and hunting. Getting sick of this place we call the great USA

[BBANBOB]

THe avg Joe who needs these gets hammered!
I have taken Oxy for YEARS on end and never addicted, but last visit to DR to get my scripts DOC told me he can give me 2 scripts in a year then I have to go to a pain specialist!!!!!!!!!!!!!!!!

I HATE THAT they want to put ya on FENTNAYL Patches and then ya WILL be addicted!!!!!!!!!!!! They are GREAT but I do not want to be on anything everyday as I don't always need it!!!!!!!!!!!!!!!!!

OH well life

[Tbone88]

Lol they have revenues near a billion every quarter and were the guinea pig for trumps war on opiates Kaka crapola bs... it’s the doctors and trailor trash selling these scripts. Why should it be big pharmas fault? This whole debacle is all thanks to Trump. One thing he’s gone way too far on. It’s not the OxyContin, it’s the Fentanyl laced with it to make fake pills from Mexico, that are then sold to teenagers and college kids. Go After the drug lords, hospitals, doctors and mom n pop shops huts handing blueberries out to everyone and anyone there for long time. The poor souls with actuall problems like cancer, neuropathy, gastroparesis, etc etc etc. they are the ones the are on the losing side of this whole bs. PHARMA should not be responsible for Incompetence, drug addicts, dealers, trailer trash and greased doctors for a script of 120 blues they can sell in the streets and $4000 for a tiny ass bottle that cost them $3 to get filled. This entire crap that Big D started really did more harm than good.

[BBANBOB]

30-50 is HIGh but should be lots higher than it is now with earnings @$8.50 for 2019

[Tbone88]

This should be at 30 to 50 a share. We will all look back at this and wish we had bought more. This is fcking ludacris at these prices. They walked it down from 134 to $1.99 on average volume. Then when it’s time to bring it up on 10 times the amount of volume over the last 3 months, they still continue to short it. I pray to God these liver trials were a success and it’s game over for these shorting scumbags.

[BBANBOB]

BEAT and earn 8.50 in 2019 and she trades at 3.50 YEA RIGHT THATS THE TICKET

Just bought more a few mins ago

Shorts in trouble here if they run into LARGE strong hands

[Tbone88]

Hahaha how bout it!! Is this a joke. Are we going to just continue to chop at this 3.50 bid in an attempt to cause panic. This is so text book it’s hilarious. Obviously shorts own this ticker. I can’t wait for the day they all fry like maggots.

[BBANBOB]

SHORTS ya got a GIFT TODAY use it!!!!!!!!!!!!!!!!!!! IMHO you're about to lose it!!!!!!!!!!!!!!!

[Tbone88]

These fliptards and day traders gots to freaking find a new stock. Really pray they all get murdered badly.

[blown632]

This is ready to launch

[dirtydozen911]

the ocera drug trail.....mnk-6106, ended yesterday...…..I would expect data out by end of month......if it looks good, as expected, they`ll probably wet our whistles with a P R NEXT WEEK

headed north for 6 weeks ...sold all the bio`s in the barn......keeping trov, and mnk…...GOOD LUCK TO ALL!

[Trend-Setter]

BioVie Submits Protocol for Phase 2b/3 Refractory Ascites Study to FDA
SANTA MONICA, CA / ACCESSWIRE / October 22, 2019 / BioVie Inc. (BIVI) ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for liver disease, announced today that it has submitted for assessment by the U.S. Food and Drug Administration ("FDA") the Phase 2b/3 clinical trial protocol for using BIV201 (continuous infusion terlipressin) to treat ascites due to chronic liver cirrhosis in patients who are refractory to or cannot tolerate diuretic therapy.
more...https://finance.yahoo.com/quote/BIVI?p=BIVI

Corporate Presentation | October 2019
https://www.biovieinc.com/wp-content/uploads/2019/10/BioVie-Corp-Presentation_website_Oct-2019.pdf

[ctcollins]

10/31/19 Mallinckrodt PLC (NYSE: MNK) said it has received Australian regulatory approval for extracorporeal administration with the Therakos cellex photopheresis system, or TCPS, which is indicated for steroid-refractory and steroid-intolerant chronic graft versus host disease in adults following allogenic hematopoietic stem cell transplantation.

[blown632]

Coiled up nicely, this will be a nice one for me!

[ctcollins]

STAINES-UPON-THAMES, United Kingdom , Oct. 31, 2019 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that UVADEX® (methoxsalen) has received regulatory approval in Australia by the Therapeutic Goods Administration (TGA) for extracorporeal administration with the THERAKOS® CELLEX® Photopheresis System. The treatment is indicated for steroid-refractory and steroid-intolerant chronic graft versus host disease (cGvHD) in adults following allogeneic hematopoietic stem cell (HSC) transplantation. The TGA also approved Uvadex in conjunction with the THERAKOS CELLEX Photopheresis System for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.

The TGA approval marks the first combined indication label and the first regulatory approval in the world for UVADEX in conjunction with the THERAKOS Photopheresis System for the treatment of chronic graft versus host disease in adults.

"The TGA approval of UVADEX with the Therakos ECP platform opens up new treatment options for patients with these challenging conditions," said Steven Romano , M.D., Executive Vice President and Chief Scientific Officer, Mallinckrodt . "The cGvHD indication is also an important milestone for Mallinckrodt , confirming the potential benefit of this therapeutic option for patients who are refractory to or intolerant of steroid treatments."

Date of first approval: 16 September 2019 . Date of revision: 11 October 2019 .

[Tbone88]

I think that’s a lil conservative being where this was just 3 to 4 months ago. This has been pummeled because of the war on opiates thanks to Big D. No reason for this dramatic decline. And now you combine it with short interest and you may have a feeding frenzy if liver trials are great on the 11th. I’m seeing more like an $8 to $12 short term possibly as high $20. End of year def double digits.

[ctcollins]

It's more likely to be around $5 by the end of the year, I'm hoping for good forecast for next year

[Phil84]

October 28, 2019 08:21 AM ET (BZ Newswire) -- News
Mallinckrodt, Inc. (NYSE:MNK) stock moved upwards by 2.5% to $3.26.
The market cap seems to be at $202.4 million.
The most recent rating by Stifel, on September 09,
is at Hold, with a price target of $8.00.

[BBANBOB]

my WAG is 6 in 6

[Phil84]

Does anyone have any ideas of what the forecast might be for MNK

[blown632]

Should be a nice squeeze over next few weeks.

[ClayTrader]

* * $MNK Video Chart 10-25-2019 * *

Link to Video - click here to watch the technical chart video

[dirtydozen911]

I jump in and out of this.........sometimes I hold a few days or so.........today I`m cashing out , and take some profit.....glta

$$$$$$$$$$$$$$$ MNK $$$$$$$$$$$$......money makin machine!!

[BBANBOB]

BOAT LOWER (SHORTS COVERING WITH HELP) AND CONSOLIDATION GOING ON as we speak!
After a run from $1.80 to 3.47 it was due!

Look for sideways to a tad up from here, then next week maybe even tomorrow a restart of the CLIMB BACK UP THE HILL!!!!!!!!!

[BBANBOB]

Not trading advice but SHORTS MAY WANT TO LOOK AT THEIR CURRENT POSITIONS HERE

[dirtydozen911]

not out of the woods yet with potential opioid claims, but looking good the last week......one of their liver studies is complete the end of oct.....this is a $50 stock.....and will be again when all the suits are settled, and they can get back to business...$$$$$$$$$$ MNK $$$$$$$$$$$....glta