Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Thing is now we have weathered the storm, the single benefit of the OTQB in the event of good news is there could be one huge liquidity squeeze on T zero for us ( of course the buffoons will say its the illegal naked shorts ) but who cares we could easily spike to $15 - $20 range
Just be sure you've got your orders in Pre Market or you`ll get trounced
Yep...agreed
Our current m/c makes us the one of the largest on OTC, if we were on Nasdaq we would be at $3-4Bn m/c right now .
there are no (longer) significant shorts to speak of , this is new longs
..the market cap impact is also pretty surprising ..
Only moving from $440m prior to TLD to $650m on TLDD dayu then settling around $560m... then b/o for $1.8bn
Def TWAP Buying
thanks , positive but will have low to no impact .
Only thing I could find was some 12 year old on Youtube talking about his interpretation , I lasted 20 seconds before I stopped it .
Link please ?
I reckon the deals already done .
well Marzan is stating the way you tell a 25 year old GBM patient to wait is to lie to them .... utter piffle ... my god ...
So you are saying they simply lied to him about Covid delays .
Well I`m from London , I drive past Kings everyday , I know the area like the back of my hand ... ITS BEEN FRIGGIN CLOSED ...
But no doubt you know better, just like when the retired twisted ex (Fired from Gartmore )stock picker Jerry Campbell who was telling us all about how Sawston would be valued ...
Anyway , I`m clicking the red button again now , I cant read anymore dilutional claptrap today
where does Joel come from ?
Maverick , it was pushed back because of Covid no more no less the friggin patient told us so !! .. please dont you start the conspiracy theories.
Last time LP borrowed cash she announced Flaskworks acquisition two weeks later .
Advent just has a £3m b/s ,she`s gonna buy it ..
then we`ll break $2.50...
....well thats when DL was announce d , I believe it had been locked at least a month before that.
So we are past 6 months now..
Sorry Sawstone is about 60 miles away and we are still in lock down.
I reckon NWBO will buy Advent very shortly
Can only mean one thing .... !! :)
Could easily happen .. any day and it really will not take much ...
I posted a 6 bullish hammers chart this morning... take a look Soj
Here`s all you need to know ...
Prof Ashkan
Surface Oncology to Collaborate with Merck on Immuno-Oncology Study Evaluating SRF388, Targeting IL-27, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors
CAMBRIDGE, Mass., March 09, 2021 (GLOBE NEWSWIRE) -- Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, announced today it has entered into a clinical trial collaboration with Merck, known as MSD outside the United States and Canada, through a subsidiary, to evaluate the safety and efficacy of combining Surface’s SRF388, an investigational antibody therapy targeting IL-27, with Merck’s KEYTRUDA® (pembrolizumab), the first anti-PD-1 therapy approved in the United States. This combination will be studied as a component of the first-in-human Phase 1 study of SRF388 and will be evaluated in patients with solid tumors, with a focus on patients with liver cancer and kidney cancer.
“Surface is the only company with clinical-stage IL-27 research and we believe that this cytokine may play an important role in resistance to anti-PD-1 treatment,” said Rob Ross, M.D., incoming chief executive officer at Surface Oncology. “This collaboration with Merck will add an important dimension to the SRF388 clinical program and allow us to more rapidly assess its potential to deliver truly breakthrough therapies that can transform treatment for people with cancer.”
In November 2020, Surface announced that SRF388 achieved predefined criteria for advancement to the expansion stage of its ongoing Phase 1 trial. Detailed initial clinical results are expected to be reported at a medical conference in the first half of 2021.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
they are my
`on ignore ` list ... peace
Novartis Says Canakinumab Didn't Meet Primary Endpoint in Phase 3 Trial for Lung Cancer Treatment
By Pietro Lombardi
(Dow Jones) -- Novartis AG said Tuesday that a Phase 3 trial evaluating the use of canakinumab to treat lung cancer didn't meet its primary endpoint of overall survival.
The Swiss pharmaceutical group said that the canopy-2 trial was evaluating the use of canakinumab, an inhibitor of interleukin-1beta, in combination with the chemotherapy agent docetaxel. The trial involved 237 adults with advanced or metastatic nonsmall cell lung cancer whose cancer progressed while on or after previous treatments.
The company said the canakinumab development program continues, with results from a Phase 3 trial expected by the end of the year.
Write to Pietro Lombardi at pietro.lombardi@wsj.com; @pietrolomb
spot on
doesn’t matter maverick , that gets flashed across Bloomberg its over ... for now at least
Are you sure ...?
CytoDyn Plunges After Covid Phase 3 Trial Data Disappoints
By Esha Dey
(Bloomberg) -- CytoDyn shares dropped over 22% in premarket trading after the company said data from its CD12 clinical trial showed the primary endpoint among all patients in the modified intent-to-treat (mITT) population was not statistically significant.
Headline's like that gets its sold , doesn't need bashers ...
We`ve been locked 6 months minimum...
Just had a 7bp bid offer ... something's gonna happen very soon ...
One real buyer and we will fly...
Oct 5th was data lock announcement.. I reckon actual lock took place long before ..
CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19
U.S. FDA Reviewing Protocol for More COVID-19 Critical Patients to be Enrolled to Support Potential EUA
CytoDyn submitted protocol to U.S. FDA for immediate enrollment of 140 critical COVID-19 patients with same sites as CD12 trial – enrollment to commence upon FDA comments
VANCOUVER, Washington, March 08, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today multiple regulatory pathways for approval of leronlimab as a treatment for critical COVID-19 patients in the U.S., U.K. and Canada.
MHRA has told the Company it will accept more data from the open-label portion of the current CD12 trial. To date, an additional 46 patients have been enrolled, but the results have not yet been communicated to any agency.
The Company anticipates the Health Canada Interim Order (IO) could allow the Company to sell leronlimab in Canada, while additional critical COVID-19 patients are enrolled. These discussions are on going, and the Company has initiated the process to submit an IO with Health Canada.
The Company also confirms the U.S. FDA has received its protocol for enrolling 140 critically ill COVID-19 patients with the primary endpoint defined as length of hospital stay.
CytoDyn is pleased to show strong data for critically ill COVID-19 patients. Considering the fact that:
(1) A higher proportion of patients over 65 were enrolled in the leronlimab arm (33%) compared to the placebo arm (23%), and
(2) Of the 384 treated patients, 117 were over 65 with an overall mortality rate 3.5 times higher (42% - 49/117) than for patients under 65 (12% - 31/267).
Therefore, an “age adjustment” analysis was performed and consequently, the updated results from the primary endpoint analysis are as follows:
1) Statistically significant results (p-value = 0.0319) reported for the primary endpoint (all-cause mortality at Day 28) in participants receiving leronlimab + “commonly used COVID-19 treatments” compared to participants who received “commonly used COVID-19 treatments” alone in the placebo group in the overall modified intent-to-treat (“mITT”) population.
2) Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant standard of care treatment (“SoC”) for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.
3) Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65.
With the age adjustment analysis in all other major secondary endpoints, there was consistent numerical superiority over the placebo group, with some secondary endpoints approaching statistical significance.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are grateful for the chance to help critically ill COVID-19 patients. We continue to be pleased with the results from over 80 EINDs, 394 patients in CD12, and another 46 patients in the continuation of CD12’s open-arm access, as well as the results published in two different peer reviewed journals. I am humbled by comments from the families whose lives they believe were saved with leronlimab and we look forward to making leronlimab more readily available to treat patients with COVID-19 and many other indications we are working on. I’m excited to address our investment community on Monday and to congratulate our entire extended team for their tireless support of the leronlimab program.”
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation by the FDA in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn was conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company suspended its Phase 2 trial for acute GvHD.
Thanks Jonny great post ,
and . Merck & Co's Keytruda Sales Fall; PD-1 Market Down 15%