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Don't underestimate Ed Walters.
Ed Walters. Google him.
Whatever?
GL
Ha-ha,
Just kidding. Ctix has never employed anyone by the name of Ed Walters, as far as I can confirm, though I've never made a call to ctix.
I'll leave it to the (short) geniuses.
One may question Leo, but don't bet against Edward Walters(or an Allergan partnership).
Someone who(can't remember who it was) sold out recently was asking yesterday, (paraphrasing) "why do longs continue to hold?"
My reason is not Leo or Dr Menon, it's this guy:
"My experience of 25 years of leadership in Clinical Operational and Project Management in the bio/pharmaceutical industry, covering all phases of clinical trials, has been one of increasing responsibilities and challenges, in designing, implementing, and successfully completing clinical programs, across various therapeutic areas. My attention to detail and proven track record of managing internal project teams and external contract personnel, has allowed me to be a part of the success of some of the leading compounds in the market today. I have a successful record of building high performing, cross-functional clinical project teams (internally and externally). I have over 25 years of direct reporting staff management experience as well as direct management of CRO/ vendor partnering. At the same time, I have always been “hands on” with every project. I have both domestic and international project management experience and extensive experience in leading clinical NDA teams on 6 Phase-III NDA Submissions to date and 5 NDA approvals."
Senior Director, Clinical Development Operations
Since his involvement, ctix trials have increased, been streamlined and updated frequently.
Oh, and he's also currently involved with a multi billion dollar company as Senior Director, Clinical Development Operations.
Look at that stock chart since his hiring.
Enough is enough. Time to call Hank Phillippi Ryan(investigative reporter out of Boston). Start with Michael Sullivan, a stone throw from her office.
Likely, perhaps.
May also be an icpi.dotuknowwhoissue.
Lead by I(perhaps others) know who.
On another note, if IPCI's portfolio is quickly proven sound, even Gruenenthal & Mallinckrodt are likely "observers from the shore" as IPCI sails quickly downstream.
The more I read about Purdue the more convinced I become that their lawyers suffer from home produced opioid abuse. I am not aware of a case they've won.
May 2007-Purdue ordered to pay $600M, and (3) executives ordered to pay $34.5M after pleading GUILTY.
October 2007- State of Kentucky(USA) sues Purdue. Settles for $24M from Purdue in 2015
2007- 26 state Attorney Generals plus the Attorney General of Washington D.C settle. Cost to Purdue, $20M. ps Many of those states, and D.c. feel they were short changed are pursuing legal avenues to pursue further.
5/22/14- Two California counties (Orange and Santa Clara) sue Purdue
8/8/16- New Hampshire Attorney General accuses Purdue of blocking probe.
9/29/16- Drug companies(including Purdue)lose bid to stay Chicago's suit
mo/d/yr- Suffolk County, NY sue Purdue
2/3/17- Broome County, NY sues Purdue
4/24/17-Rockland County, NY sues Purdue.
After reading all this(with minimal search, I bet there's more), I don't see how Purdue would be acceptable to IPCI as a partner(don't think Odidi's would want any association with them).
Grünenthal Group is my bet for any type of partnership. Mallinkrochet a close second, particularly given the big sale of one of their units.
Long story short, don't think IPCI would want to get entangled with a company like Purdue, a company that is ascending an avalanche trail.
Another patent issued today:
Patent # 9636306
Proton pump-inhibitor-containing capsules which comprise subunits differently structured for a delayed release of the active ingredient
Type: Grant
Filed: Jul 10, 2014
Date of Patent: May 2, 2017
Patent Publication Number: 20140322312
Assignee: INTELLIPHARMACEUTICS CORP. (Toronto, Ontario)
Inventors: Isa Odidi (Toronto), Amina Odidi (Toronto)
Primary Examiner: Kyle Purdy
Application Number: 14/327,701
The responders clearly feel threatened, imo(they responded loudly).
Sent the thread to my(Massachusetts) governor.
Please respond publically.
"No matter what one wants to believe, it's all water under the bridge. The stock went to 5.00 well past that info. "
What info are you referring to?
"The stock has been on decline because of B.S hit pieces, a strong market, tired and impatient investors, and a company not making any money."
Perhaps, no argument there. Reason for a visit, I'm now concerned.
"If one wants to use a credibility issue as an excuse, that is their prerogative."
Agree. One should be open-minded and ask questions to them selves and presenters of information.
"The only thing I am looking at is the progression of trials and results. And so far it's been perfection. Everything else is just noise."
We are led to believe that, because of their brain power, forward-looking statements, and press releases, we should trust every utterance spewed, yet they know not how to proofread their own statements?
Slopiness breeds inefficiency, and the share price has followed Leo's efficiency(or lack thereof(a car can still run on a bad timing chain(for a while)).
I can't speak for loan ranger, but believe he's inferring that either someone lied, or this group is not nearly as intelligent as they portray themselves.
We are led to believe that, because of their brain power, they are at the cusp of some first in class products, yet they know not how to proofread their own statements?
Slopiness breeds inefficiency, and the share price has followed Leo's efficiency(or lack thereof(a car can still run on a bad timing chain(for a while)).
Proximity to any company one is invested in determines the cost of a visit(airfare, hotel, meals, etc). Ctix is located on the north shore of Massachusetts, less than an hour from me. I'm quite willing to request a meeting, drive 100 miles round trip, ask some questions, assess the answers, atmosphere, and surroundings and determine if I'm comfortable with this investment. Done it with a few companies.
you "may be" right, most likely not. Regardless few have defamed leo the lion, he's accomplished that himself. He's sunk his own ship, as evidenced by the share price performance this past week, month, year, and beyond. Check any chart.
I, fortunately, am right in his (their) backyard.
p.s- Casey was a PLAYER, not a MANAGER. leo and menon are MANAGERS.
Beginning to view this team in terms of baseball as well. Leo and Menon remind me of Marge Schott and Pete Rose.
Do you understand the difference between frightened and pissed? Never panic in a rip tide, but nor do I choose to body surf out with one. I prefer to ride the waves into shore.
This stock, more than most, has been in major rip for a long time. They were trading $1.50+- around Thanksgiving. One must be short if one is happy with sp performance.
Clearly, the limited market that tracks ctix was not impressed with the "cc"(down 20.59% as I type).
If the trend is your friend, we are in unfriendly waters.
I was long but must say, after the pre-ceremonial announcements to this "CC"(that should not legally be defined as a cc, if it is, got a call get a call into Ashcroft AND Rosen to inquire) he has lost any cred he may have had with any that were in his camp prior to 11am today. Underhanded Leo has me pissed off. Thank God I live in the Boston area and have siblings/relatives/inlaws in the medical profession in Boston. A few with media/legal ties as well.
What they pre-promoted last week was unnecessary, and clearly provided no real beneficial, or new information today. It was a rinse and repeat of old news, simple as that, "protected" by forward looking statements.
We'll see.
Leo Erlick must be forced to resign.
,
"He cannot give news such as partnership in cc."
Why not? What if they release a pr simultaneously (same time) with the cc, and get into more detail via the cc?
Who knows what he'll announce. Could be something on kevetrin if they had some early recruits. The trial started on 2/17/17. Patient(s) are to be treated 3x/week for 3 weeks, then evaluated for 3 weeks(once each week?) by comparing the tumor biopsies before and after treatment. If one or more patients were treated on 2/17/17, last biopsy theoretically would be 3/31/17.
But, who knows?
ipci.ca and samsa1 will take this down:)
I should add that all 3 are shown as recruiting.
Psoriasis study updated over the weekend. Added three more sites. Kansas(Overland Park), Texas(Austin), and Virginia((Charlottsville).
28 locations now.
Bertolino has good qualifications. No doubt, but my mind, Walters is the task master, and master of communications, to all levels.
Though sp peaked, and since declined, since his hiring, his execution, I believe, is why we are where we are at.
And why we are soon to skyrocket.
I think Ed Walters will prove to be the wise one if things work out. I believe it is Walter's who recommended the new hires after the ctix bought out Polymedix(who Walter's worked for). His linkedin page still lists him as Senior Director, Clinical Development Operations of Allergan and Head of Clinical Operations of Ctix. Perhaps he still has his consultant business and maintains those tiltles through his business?
Who knows. He seems to make sure that the clinicatrials site remains current, which alot of bt's can let slip.
I think he's the one who reads the tide charts, is cognizant of the shifting winds, monitors the depth gauge, and adjusts the sails, and course, to best assure safe passage.
He bailed Leo out and, perhaps, vise versa. I would be concerned if Walters left verse anyone else.
If you consider the $12000 as interest, that boils down to .5% interest, applied one time. Beats any annualized loan out there.
Almost hard to believe.
Wonder if the balance of the Odidi's loan has been paid off? Tomorrow is the deadline. No filing w sec to indicate ipci has requested another extension...yet.
10M, enough to get them through 2 qtrs+- based on last qtly "earnings" of -.17/sh
How's that for "a nice Hawaiian punch"? That vitamin C article may have put ctso sp into septic shock, so to speak.
Hope not.
Karin,
I would use the word rightfully in lieu of thankfully.
Though not the outcome I'd hoped, I believe it will bode well for all the lawyers involved(Sullivan, Rosen, Failla), and we shareholders.
I believe the Achilles heel of the argument was Sullivan(Ashcroft) taking compensation in shares, then presenting his argument that the plaintiff(Rosen) should provide compensation for the defendants attorney fees when no monetary exchange occurred.
Maybe the Ashcroft law firm ponied up today's dough?
The anticipated milestones shown on page 6 of Feb 2017 corporate overview still shows Psoriasis- Interim Analysis Ph2b happening in the first half of 2017...anytime between today and 6/30/17.
I'm guessing Sullivan's use of Section 78u-4(c) and his refernce to Judge Failla of rule 11(b) has Judge Failla's clerks is making Rosen uncomfortable, and her law clerks leaving no stone unturned. From what I read, although the Private Securities Litigation Reform Act of 1995(PSLRA), sited by Sullivan, section 78u-4(c) is often not brought up by attorneys. Sullivan has brought it up. From www.law360.com- "When invoked, Section 78u-4(c) has teeth. The PSLRA “establishes a presumption that, for substantial failure of any complaint to comply with any requirement of Rule 11(b), the award shall be the full amount of the reasonable attorneys’ fees and costs.”
Another cut &paste: Section 78u-4(c) further mandates that courts impose sanctions where it determines that Rule 11 was violated:
(2) Mandatory sanctions. If the court makes a finding under paragraph (1) that a party or attorney violated any requirement of Rule 11(b) of the Federal Rules of Civil Procedure as to any complaint, responsive pleading, or dispositive motion, the court shall impose sanctions on such party or attorney in accordance with Rule 11 of the Federal Rules of Civil Procedure. Prior to making a finding that any party or attorney has violated Rule 11 of the Federal Rules of Civil Procedure, the court shall give such party or attorney notice and an opportunity to respond.[2]
Finally, 11(b) rules:
Representations to the Court. By presenting to the court a pleading, written motion, or other paper—whether by signing, filing, submitting, or later advocating it—an attorney or unrepresented party certifies that to the best of the person’s knowledge, information, and belief, formed after an inquiry reasonable under the circumstances:
(1) it is not being presented for any improper purpose, such as to harass, cause unnecessary delay, or needlessly increase the cost of litigation;
(2) the claims, defenses, and other legal contentions are warranted by existing law or by a nonfrivolous argument for extending, modifying, or reversing existing law or for establishing new law;
(3) the factual contentions have evidentiary support or, if specifically so identified, will likely have evidentiary support after a reasonable opportunity for further investigation or discovery; and
(4) the denials of factual contentions are warranted on the evidence or, if specifically so identified, are reasonably based on belief or a lack of information.
Rosen, me thinks, screwed others first, then themselves(thanks to Michael Sullivan). Time will tell.
The detailed description has not changed, patients will be treated for up to seven weeks.
Detailed Description:
This study will examine whether daily oral rinses with a solution containing brilacidin will prevent the occurrences of OM or lessen the severity of OM if it occurs. Patients will use an oral rinse 3 times daily for up to seven weeks during chemoradiation for head and neck cancer.
I read it as, after 7 weeks, they will assess the incidence of ulcerative and severe oral mucositis (as WHO Grade ≥3) and after 11 weeks they assess the incidence of Treatment-Emergent Adverse Events(no change from the previous timelines for either of these two parameters).
The timelines for each secondary outcome measure has been changed from 7 weeks to 11 weeks. As Cabel noted, since the timeline of one of the primary outcome measures(incidence of Treatment-Emergent Adverse Events) was already 11 weeks, these changes should not alter the completion date.
Summary, no extension to treatment time nor trial duration.
How bout a nice Hawawiian Punch? Loaded with vitamin C!)
JK, interesting article . Thanks for the post.
My question is, is the quote about cash enough to see them through June 2018 accurate?
Don't think it came from Dr Odidi as it is not in quotes. Came from either McGovern(the reporter), or Aegis(noted source). Who knows?
Liked this from mnk today:
TAINES-UPON-THAMES, United Kingdom, March 20, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading specialty pharmaceutical company, announced today it has closed the sale of its Intrathecal Therapy business to Piramal Enterprises Limited's subsidiary in the U.K., Piramal Critical Care, for approximately $203 million, including fixed and contingent consideration. The company's Intrathecal Therapy business markets products for the treatment of spasticity via intrathecal drug delivery, including the key asset Gablofen® (baclofen injection).
Mallinckrodt's divesture of this business is aligned with the company's ongoing focus on driving return on invested capital, and contributes to the strategic transformation of the company.
"This action is another example of the strategic evolution of our portfolio, and will free resources for investing in our growth platforms in autoimmune and rare diseases and hospital therapies," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. "Our Intrathecal Therapy business is an excellent fit for Piramal Critical Care, and is the best solution to meet patient needs."
The approximately $203 million transaction will consist of $171 million of fixed consideration of which 10%, or $17 million, will be paid at closing, and an additional $154 million will be paid on the first anniversary of the close date. The remaining total consideration of up to $32 million is contingent, based on the gross profit of the Gablofen products in 2018 and 2019.
Gablofen, a product approved by the U.S. Food and Drug Administration (FDA) for use in management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above, is the only FDA-approved baclofen in prefilled syringes and factory-sealed vials.
About Gablofen
Gablofen is indicated for use in the management of severe spasticity of cerebral or spinal origin. Approved by the FDA in late 2010, Gablofen is a branded, AP-rated alternative for Lioresal® Intrathecal (baclofen injection) and is listed in the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
PLEASE SEE IMPORTANT RISK INFORMATION, INCLUDING BOXED WARNING BELOW.
INDICATIONS AND USAGE
Gablofen (baclofen injection) is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above.
Gablofen should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses.
Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump.
Spasticity due to traumatic brain injury: wait at least one year after injury before considering Gablofen therapy.
IMPORTANT RISK INFORMATION
WARNING: DO NOT DISCONTINUE ABRUPTLY
Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.
Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g., spinal cord injuries at T-6 or above communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional post-implant clinician and patient information.
CONTRAINDICATIONS:
Hypersensitivity to baclofen.
Do not use Gablofen for intravenous, intramuscular, subcutaneous or epidural administration.
WARNINGS AND PRECAUTIONS
Risk of life-threatening overdose during pump refills. Use extreme caution when filling the Medtronic SynchroMed® II Programmable Pump which is equipped with an injection port that allows direct access to the intrathecal catheter. Direct injection into the catheter through the catheter access port may cause a life-threatening overdose.
Use only with Medtronic SynchroMed II Programmable Pump (or other pumps labeled for intrathecal administration of Gablofen (baclofen injection)).
Potential for contamination due to non-sterile external surface of prefilled syringe. Although the drug solution and pathway in the Gablofen prefilled syringes are sterile, the external surface of the prefilled syringes (all strengths, including the 50 mcg/mL strength) are non-sterile and have the potential to lead to contamination and consequent adverse reactions. The use of Gablofen prefilled syringe in an aseptic setting (e.g., operating room) to fill sterile intrathecal pumps prior to implantation in patients is not recommended, unless the external surface of the prefilled syringe is treated to ensure sterility. Gablofen supplied in vials may be used with conventional aseptic technique to fill intrathecal pumps prior to implantation.
Resuscitative equipment and trained staff must be available during screening dose, dose titration, and refills due to the potential life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure.
Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.
Use with caution in patients with psychotic disorders, schizophrenia or confusional states as it may exacerbate condition(s).
Fatalities have been reported with intrathecal baclofen use.
Caution should be used in patients with a history of autonomic dysreflexia.
Presence of infection may increase the risk of surgical complication and complicate dosing of Gablofen.
May cause drowsiness: use caution in operation of automobiles, dangerous machinery and activity made hazardous by decreased alertness. Other CNS depressants and alcohol may add to this effect.
Potential development of intrathecal mass formation. Clinicians should monitor for signs and symptoms of new neurologic symptoms including the use of imaging diagnostic modalities.
Oral baclofen use has been associated with a dose-related increase in incidence of ovarian cysts.
SERIOUS ADVERSE EVENTS:
Sudden withdrawal of Gablofen can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death. Inform patients that early symptoms of Gablofen withdrawal may include increased spasticity, itching, and tingling of extremities. If Gablofen withdrawal or a pump malfunction is suspected, patients should be brought immediately to a hospital for assessment and treatment.
Gablofen overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.
Other serious adverse events may include: potential development of intrathecal mass formation, drainage, infection, meningitis, unmanageable trunk control, CSF leakage, coma and death.
COMMON ADVERSE EVENTS:
The most common adverse reactions in patients with spasticity of spinal origin were hypotonia (25.3%) somnolence (20.9%), dizziness, nausea/vomiting, hypotension, headache, and convulsions.
The most common adverse reactions in patients with spasticity of cerebral origin were hypotonia (34.7%), somnolence (18.7%), headache (10.7%), agitation, constipation, leukocytosis, chills, and urinary retention.
Other common adverse events may include hypoventilation, hypertonia, paresthesia, increased salivation, back pain, pruritus, diarrhea, peripheral edema, asthenia, pain, confusion, speech disorder, amblyopia, accidental injury and dry mouth.
For Full Prescribing Information about Gablofen, click here.
About Mallinckrodt
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. 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; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. 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.
Cautionary Statements Related to Forward-Looking Statements
Statements in this document that are not strictly historical, including statements regarding future financial condition and operating results, economic, business, competitive and/or regulatory factors affecting Mallinckrodt's businesses and any other statements regarding events or developments that we believe or anticipate will or may occur in the future, may be "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: general economic conditions and conditions affecting the industries in which Mallinckrodt operates; the commercial success of Mallinckrodt's products; Mallinckrodt's ability to realize anticipated growth, synergies and cost savings from acquisitions; conditions that could necessitate an evaluation of Mallinckrodt's goodwill and/or intangible assets for possible impairment; changes in laws and regulations; Mallinckrodt's ability to successfully integrate acquisitions of operations, technology, products and businesses generally and to realize anticipated growth, synergies and cost savings; Mallinckrodt's ability to successfully develop or commercialize new products; Mallinckrodt's ability to protect intellectual property rights; Mallinckrodt's ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; customer concentration; Mallinckrodt's reliance on certain individual products that are material to its financial performance; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; the reimbursement practices of a small number of public or private insurers; pricing pressure on certain of Mallinckrodt's products due to legal changes or changes in insurers' reimbursement practices resulting from recent increased public scrutiny of healthcare and pharmaceutical costs; limited clinical trial data for H.P. Acthar Gel; complex reporting and payment obligations under healthcare rebate programs; Mallinckrodt's ability to navigate price fluctuations; future changes to U.S. and foreign tax laws; Mallinckrodt's ability to achieve expected benefits from restructuring activities; complex manufacturing processes; competition; product liability losses and other litigation liability; ongoing governmental investigations; material health, safety and environmental liabilities; retention of key personnel; conducting business internationally; the effectiveness of information technology infrastructure; and cybersecurity and data leakage risks.
These and other factors are identified and described in more detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the fiscal year ended September 30, 2016. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
CONTACTS
Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
cole.lannum@mallinckrodt.com
Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
daniel.speciale@mallinckrodt.com
Media
Rhonda Sciarra
Senior Communications Manager
908-238-6765
rhonda.sciarra@mallinckrodt.com
Meredith Fischer
Chief Public Affairs Officer
314-654-3318
meredith.fischer@mallinckrodt.com