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My point earlier. No timelines here. Results will overwhelm FDA daily. Go CYDY.
Chump
Collect your thoughts. Hold still-https://emcrit.org/pulmcrit/pulmcrit-eleven-reasons-the-nejm-paper-on-remdesivir-reveals-nothing/
CYDY says no problem with us while in the huddle.
Chump
Yep in the news cause it isn't as company previously pumped it was. Thanks for the reminder of CYDY. https://thehill.com/policy/international/492460-small-chloroquine-study-stopped-after-irregular-heart-beats-detected-in
Study on halt. WHY ISN"T IT ON CLINICALTRIAL.GOV ? Where is CEO background and lawsuits not provided. Fake drug.
Chump
Blueheel1- I agree. Get the popcorn out. Very soon it will be self propelled.
Chump
BLA maybe May but doubt it. Overwhelmed with COV but the COV attention will more acceptable by FDA from the COV results. All ties in.
Chump
Definitely not 6 weeks. Not to sound harsh but if a treatment took 6 weeks to get results the patient would've already passed. 6 weeks is just FDA protocol. CYDY results are weekly.
Chump
Bobbythebus. FDA said 6 weeks. Lero results are coning in for patients in 2-4 days off ventilators. FDA will take the results as submitted per patient. Expect daily results since it's multiple patients throughout many different hospitals all treating on different days. As for BLA. I expect submission any day. Can only imagine 25 hospitals and throw in the patients and the correspondence involved. I'm quite content.
Chump
stockaudit- Nice. It puts a narrative on the FDA is giving them 6 weeks but if you have the data in 2-5 days we (FDA) will eval asap and move forward.
Chump
fsoalex- Agree. This week will bring more stellar patient results as they start rolling/reported in.
Chump
With CYDY's Pr's and unsolicited news medias hitting the wires their med/results are unquestionable. It's illegal to yell fire in a theater and also tout something as false knowing it's the truth. More supportive national news will flow. Matter of time and all outside issues will be addressed by CYDY. Posty note for now while COV is requiring all resources.
Chump
CYDY News PR's exposes/ proves there are some "SICK" people in the world.
Chump
Amatur17- PE multiples are in line.
Chump
Bobbythebus- Just like the placebo which we all disagree with. The FDA is on a scramble trying to follow protocol but also relaxing guidelines at the same time. Placebo and timeline will be changed mid flight. So to answer your question: Yes SP will go gradually up as these positive results continue flowing and guidelines are relaxed and media picks up on the success. We won't be waiting 6 weeks we will are on the any day calendar. Too many different Dr's throughout the country commenting to the FDA instead of 1 in an isolated trial location.
Chump
Amatuer17- JMO- but maybe the moderate to mild treated because the placebo allowed? Maybe clarification later. Certainly disagree with placebo on critically ill. Don't know but it is fast paced and modifications will probably be made.
Chump
April 13 2020- https://infosurhoy.com/health/two-covid-29-patients-taken-off-ventilators-days-after-experimental-treatment/
Two COVID-29 patients taken off ventilators days after experimental treatment
By Denis Bedoya On April 13, 2020 In Health Leave a comment
Two coronavirus patients in New York City were treated with a new drug ‘fast-tracked’ for HIV and breast cancer – and they went from being on ventilators in the ICU to regular hospital in a matter of days.
Based on the results of a small initial trial, biotech firm CytoDyn believes their drug, leronlimab, has potential for treating patients severely ill with coronavirus.
They believe that the drug can quell the ‘cytokine storm’ – a deluge of immune cells that can be as damaging as the infection itself – that triggers life-threatening lung inflammation in coronavirus patients.
Leronlimab has only been tested in seven critically ill patients thus far, but two are now free from ventilators, and another two more show signs that the severe inflammation sending their lungs into organ failure are subsiding.
There are no approved treatments for coronavirus, but the CytoDyn’s drug is among the latest being tested to help save the lives of Americans with coronavirus, of which there are now well over 100,000 – and if it continues to show promise it could get FDA approval in as little as little as six weeks.
Developing a drug that targets the coronavirus itself take time and money – both of which are in short supply in the face of the COVID-19 pandemic.
Scientists, universities, and the World Health Organization are all racing to test existing drugs or those in development against the virus that has already killed more than 1,500 Americans.
Among those is a drug that has already been fast-tracked by the US Food and Drug Administration for treating another virus – HIV – as well as cancer.
Leronlimab is already in trials and showing promise for treating HIV.
But scientists CytoDyn think that their drug’s benefit for coronavirus patients is not an antiviral one.
What’s killing coronavirus patients is a complication of the virus: pneumonia.
The virus binds to lung cells, and the immune system kicks into high gear to fight the infection with every weapon it has, despite the fact that we do not have antibodies specific to COVID at the ready.
This flood of immune cells, including cytokines – the immune system’s communication system.
Cytokines tell the immune system to send a deluge of chemicals from white blood cells to attack the infection, causing inflammation.
When inflammation gets out of control and fluid starts to fill the alveoli in the lungs, a patient develops pneumonia.
In the case of many of the sickest coronavirus patients, this leads to acute respiratory distress syndrome (ARDS), a condition that requires ventilation, and even then can prove fatal.
Leronlimab interrupts this domino effect by calming the cytokine storm.
It’s not entirely clear how the drug does this, but it’s a phenomenon that CytoDyn has seen not only in its first small set of coronavirus patients but in 840 HIV patients who saw significant reductions in their levels of inflammation.
For their COVID-19 trial, doctors at a New York hospital gave the drug to seven severely ill coronavirus patients.
The drug is given via two injections – one on each side of the abdomen.
For the first patient, a person in their 70s, improvements came almost immediately, and were considerable, from what the doctor overseeing the trial told the company’s president.
‘One of [the patients] self-extubating,’ meaning they removed their own ventilator tube, ‘and was alert an hour or two after treatment,’ CytoDyn president Dr Nader Pourhassan told DailyMail.com.
‘The doctor said that this patient, in the last three days before treatment, was intubated and extubated and every time they intubated him, within four to six hours they immediately had to intubate him again.’
Since the patient pulled out their own breathing tube, they’ve been doing well and has been off the ventilator.
This patient as well as the second patient treated have both now been taken off a blood pressure drug that was being used to help them cope with the distress of COVID-19 too.
Three days after the first injections of leronlimab were given, bloodwork from these and two other patients showed that the cytokine storm was subsiding.
A second dose of leronlimab was given a week after the first.
All but one of the patients have so far been steadily improving.
Dr Pourhassan says that the company is less than two weeks from turning in all their filings to the FDA for approval of leronlimab for HIV treatment.
The drug’s fast-tracked status means it could be approved for HIV in as little as six months, but the FDA has also already asked for a second protocol to approve leronlimab for further coronavirus testing.
CytoDyn is set to give the drug to another 75 patients with mild or moderate coronavirus, and if they, like the first set of patients, show signs that ‘the cytokine storm goes down and the patient is not having a problem clearing the virus…it could get FDA-approval very quickly,’ said Dr Pourhassan.
The doctor running the trial in New York – who must remain anonymous until the FDA says the hospital and doctor’s name can be revealed – told Dr Pourhassan drugs showing promise for coronavirus could be approved in as little as six weeks.
KMBJN- Apologize. They were from another very accredited poster. I'll see what I can do bout the links. Thanks
Chump
Bobbythebus- No. At the beginning they said discussions on treatments and was curious. False alarm on my part.
Chump
Amatuer17- Again good observation. IMO I do not think Clinicaltrial.gov site is current or even being maintained. My point to look there for current info should be cautioned. There are several other Non CYDY trials underway for COV not listed there also. It's a major shutdown nationwide. We haven't felt the final impact yet.
Chump
MSNBC is going to talk about New York and possible treatments in a few mins. Don't know what's in store. Will watch.
Chump
All please email CBSLA story to them: https://www.cbsnews.com/news/scientists-rush-to-develop-novel-coronavirus-vaccine-60-minutes-2020-03-22/
Chump
Amatuer17- valid observation but yes all FDA energy is on COV.
Chump
tonusd57- Ha! my ticker is good. Just determined to get a leg up on CYDY board. Great blasts you put out and yes next week is gonna be real cool for patients and longs.
Chump
Blueheel!- Happy Easter to yours also. Not to be flippant at all towards you but CYDY isn't planning on giving this away. In the trials maybe at first but reimbursement and future needs/orders to hospitals will get it as a grant due to it being "not off the shelf". Basically, anything to stop this there is money for it.
Chump
New York Times. Letter to the Editor: WHAT YOU’RE SAYING
Here’s what readers had to say about the last debate: When will there be a treatment for the coronavirus?
Readers wrote in to note two other potentially promising drugs that are undergoing clinical trials: Leronlimab, a monoclonal antibody developed to treat H.I.V., and recombinant interferon alfa-2b, a protein that functions as an immune system messenger.
Chump
elking- grant coming to fund CYDY on it's current n future trial due to it's success.
Chump