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Judge Du has proven with the standard of clear and convincing evidence that she is an absolute moron and disgrace.
Jup, hope Judge Du is proud of herself...
What a turd lol.
Nice! Good luck!
Yeah, they released the news again on Friday after they seemed to feel they didn't get enough attention on their readout lol.
Any idea why the market's response has been so luke-warm? (other than general market); the 0.04 p-value perhaps?
Agree. At $35 market cap, this is extraordinarily cheap, especially now that the first Phase 3 study read out positively... Initiating a position today.
Unbelievable, right? What a disingenious ***. Jup, he posted he sold most of his shares on Yahoo board.
What happened here is borderline criminal...
Management should be ashamed...
And excellent case-study of value destruction through a mix of unfortunate management decisions and bad luck.
Re-entry late this year.
The clock has likely been reset due to the additional data submission in February, so likely April.
In any case, it is probable that FDA might ask for more data. Keeping fingers crossed, but...
Enhancing shareholder value :D
My bad...
That's not true. It would also consist of pumping in the iHub intro: - where are the millions of revenue LMAO
"RBNW IMPORTS - MILLIONS COMING IN - HUGE
Over the last month they’ve imported 50,000 kg
of inventory evidenced by these U.S. Custom’s records.
Revenue is clearly already in the millions of dollars.
11 million float - we see the same pressure as Friday"
this will be at .50 in no time.
OUCH! WHAT A PUMP AND DUMP POS PONZI SCHEME!
Why don't the ones "loading up cheapies" don't propose a tender offer and take the company private? When it's private, the MMs can't manipulate the SP anymore and it's true value is unlocked...
Unless... the value is ZERO! LMAO
Oh yes... along with the billion shares yet to come LMAO
OUCH! THIS TURD SCAM IS TANKING AGAIN!
I wouldn't rule out another smaller raise, but it is enough to get to the funding decision and readout in May. Cash at the end of Q2 will be about 7m.
I like the clinical results so far, so let's see if they can score a win for SH.
They raised 4m in January through Jeffries. Net loss last quarter was 6.7m, so closer to 7m.
That should carry them to the interim readout in May. Around that time the funding decision by the European Commission will be due too.
WOW WHAT A DUMPSTER FIRE SCAM!
"Company generates millions in Revenues"
...and billions of shares.
But go on, accumulate more cheapies. You'll all be millionaires.
Tender offer: I am offering to acquire the whole company for $1 total and bring the scammers here into prison and the company before court. This extremely generous offers expires tomorrow.
Wow, what a shocker that a scam goes down and down and down lol
You're welcome... Let's see whether they bring it on during the next months :)
Fair enough. Bought a starter on Friday.
Yes, sooner or later they have to execute.
Well, an important readout is due soon (April/May); European commission funding decision and so on.
Seems like a possible turnaround is close
He made my day lol
I am :)
You confuse this board with RBNW
Yeah, the price always drops when huge buying takes place lol
Near-term Milestones/Catalysts
Soon: Feedback from BARDA for a project designed to demonstrate the superiority of our PLX-R18 therapy versus current standards of care in the treatment of Acute Radiation Syndrome (ARS).
Q2 (May?): Interim analysis of efficacy (one-year follow-up) for the Phase 3 study in CLI; potential for AA under the EMA's Adaptive Pathways project; full enrollment of study.
May: Possible award by the European Commision for novel regenerative medicines through the RESTORE Consortium, of which Pluristem is a leading member (up to 1b€).
Q3-Q4: Full-enrollment in the Phase 3 study in mucscle recovery; results in Q1-Q2 2021.
Awwww, grumpy that no one wants to join your miserable asshat choir?
Back to your shift, Mr Executive. People are waiting for you yelling at them.
Yup, very disappointing.
At this rate, they will likely need to raise at 2-3.
Selling my position and coming back next year.
HOUSTON, Feb. 11, 2020 /PRNewswire/ -- Marker Therapeutics, Inc. (MRKR) (NASDAQ: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Marker's planned trial investigating safety and efficacy of its novel MultiTAA T cell therapy in patients with post-transplant acute myeloid leukemia (AML).
https://mma.prnewswire.com/media/771253/Marker_Therapeutics_Logo.jpg
Marker previously announced on November 12, 2019, that the FDA placed the trial on clinical hold. The FDA requested additional information and technical specifications for two legacy reagents supplied by third parties used in the MultiTAA-specific T cell manufacturing process. The technical specifications and data requested by the FDA could not be produced by the original suppliers. The Company identified alternative suppliers, satisfying the Agency's request.
Based on data Marker provided, the FDA permitted the Company to initiate its AML trial, beginning with a safety lead-in portion. The FDA placed a partial clinical hold on the trial for the use of the MultiTAA-specific T cell product manufactured using one of the reagents supplied by the alternative supplier, until the final data and certificate of analysis for the reagent are reviewed and accepted by the Agency. The safety lead-in portion of the trial is expected to enroll approximately six patients as part of the amended trial design. Three patients will be dosed with MultiTAA-specific T cells manufactured using the legacy reagent, and three patients will be dosed with T cells manufactured using the reagent from the alternative supplier.
Marker currently estimates that the alternative supplier will deliver the final reagent, along with the final data and certificate of analysis required by the FDA, by the end of the second quarter of 2020. Marker anticipates to complete enrollment of the first three patients and submission of the final technical specifications and comparability data of the new reagents to the FDA during the second half of 2020, thereby satisfying the requirements for lifting the partial hold on the clinical trial. Given this expected timing, Marker does not currently expect the partial clinical hold to significantly impact site and patient enrollment of the AML trial.
The safety lead-in will be followed by the 160-patient randomized portion of the study at approximately 20 transplant centers. Group 1 will comprise 120 adjuvant (disease-free) patients, with the primary endpoint of relapse-free survival of patients receiving MultiTAA-specific T cell therapy versus a control group. Group 2 will comprise 40 active disease patients in a single arm, with primary endpoints of complete remission and duration of complete remission.
"With a clear path identified for getting our study of MultiTAA-specific T cell therapy underway in patients with AML, we're focused on addressing the remaining requirements from the FDA and enrolling up to 20 clinical centers to conduct our Phase 2 trial," stated Peter L. Hoang, President and CEO of Marker Therapeutics. "We appreciate the productive dialogue with the FDA throughout the process and look forward to advancing MultiTAA-specific T cell therapy for patients with post-transplant AML in a randomized and multicenter clinical trial."
SEC would rather spend time on investigating shoe scams and prosecuting shoe scam pumpers.
Someone on SA got in touch with Nader as to the rationale for 350mg in the basket trial:
"So I asked NP why the decision was made to use 350mg for the basket cancer trial when higher doses were seen as safe, and if he wasn’t worried that this lower dosage would negatively impact efficacy?
He answered:
“We will address all this at our next presentation. For now please note that 350, 525, and 700 mg all will be considered and our amazing results for patient #1, 3 and 4 were with 350 mg. Patient #2 was allowed to receive 700 mg.”
Not sure about anyone else, but I was unaware that patients #1, 3 & 4 were treated at 350mg. I guess I assumed 700mg, but now that I think about it, it makes sense as this is probably what the FDA wanted for the mTNBC trial at the time. This fact makes the cancer results even a little more impressive, and makes one wonder what extra effects, if any, the higher doses might bring?
Thanks to NP for answering and so quickly."
Yes, let's hope for the best, but after what has happened with the combo approval process, I have become suspicious of FDA...
Did the PR explicitly mention that the basket trial too would have a dose escalation design like the mTNBC trial? Would be logical...