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Just to be clear, dcth does not currently have a trial for hepatocellular carcinoma, however I believe they have finished a phase 2 trial back in like 2013 I think.
Just posted the news for you. Keytruda failed their hepatocellular carcinoma trial. I don't believe opdivo will do any better. Imo this is really good news.
"The pharma giant reported after the market closed on Tuesday that Keytruda failed the KEYNOTE-240 study for hepatocellular carcinoma, the most common type of liver cancer. The trial missed on both overall survival as well as progression-free survival. That news arrived just 3 months after the FDA offered an accelerated approval on liver cancer based on their earlier mid-stage data for the drug."
"Merck was quick to note that it’s studying Keytruda in a range of other liver cancer studies, but the advantage here has clearly switched to Opdivo for now, which has been dragging steadily behind Keytruda after falling short on lung cancer, where Merck holds first-line advantage."
https://endpts.com/mercks-phiii-liver-cancer-study-for-keytruda-fails-on-two-key-endpoints-just-three-months-after-the-fda-gave-it-the-green-light/
I agree with you. Also, to be clear I'm definitely not recommending anyone to fire walk with me.
I do think this would have had FDA approval already if it were owned by a bigger company. However, even though technology continues to progress, their trials continue to demonstrate that their are no better alternatives for this type of liver cancer. Immunotherapy plus chemo just doesn't work well for this type of cancer and other targeted therapies don't seem to work any better. As for other types of cancer it may be true that their are just already better alternatives out their already, but since there really is no cure for all cancers there may still be a niche for this product.
I think it really depends on the drug they use and how the combo effects the specific cancer - and if there is not already a standard of care that is better. But in some places the doctor can choose when they prescribed something that has been approved.
Arterial perfusion is not uncommon for different purposes, and even the addition of filtration is used in other procedures. Chemosat is the drug, filter, and the procedure. There is another company that they worked with back in the day to develope their filter that uses them to filter out things like biological weapon attacks and things off the nature.
There have been some major issues along the way for this company that really held them back imo besides all of the RS bs and bad deals. For one, during the original trials people died and it wasn't properly reported - they mostly died because they hadn't gotten down the procedure yet. Dcth was also forced to use a different filter half way through the trial, I believe it was something to do with the manufacturer of them and FDA didn't want to use the data since it was not the same filter. They initiated a new trial and for some reason - probably because Jennifer is not a business person/ maybe FDA vendetta - agreed to an unreasonable amount of trial patients that couldn't really be met because the disease is rare. Then to top it all there is now an effective treatment to ocular melanoma that causes the liver cancer they want to treat.
FYI I'm not a doctor or in the medical field so I might have misspoke.
This is what I was referring to: Minimum Value To Delcath Expected To Be Approximately $10 Million
NEW YORK, Feb. 9 -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment system for primary and metastatic cancers to the liver, announced today the signing of its first research, distribution, sales and marketing agreement for its Percutaneous Hepatic Perfusion (PHP) System (the Delcath PHP Systemâ„¢). The agreement grants Chi-Fu Trading Co., Ltd. the exclusive right to market and sell the Delcath PHP System in Taiwan for hepatic malignancies and infectious disease upon Taiwan Food and Drug Administration (TFDA) approval, and any other approved use, with a conditional option for Singapore.
Under terms of the agreement, Chi-Fu will fund and manage clinical studies at up to four sites to gather data for submission to Taiwan government regulatory agencies for approval. Any regulatory filings will be in the name of Delcath Systems, Inc. For the clinical studies, Chi-Fu will purchase, at a discount, Delcath PHP Systems to treat up to 200 patients with hepatic cancer. Any additional systems required will be sold at a confidential distributor price. It is intended that at least two of the clinical study sites will become reference sites when the studies are completed.
Under the terms of the agreement, Delcath is to receive $1 million in milestone payments, comprised of $300,000 upon execution of the agreement and the balance upon receipt of the CE Mark and upon receipt of FDA approval. In addition Chi-Fu will be contractually committed to purchase a minimum number of systems annually during the term of the agreement, commencing when commercial sales begin in Taiwan. The term of the agreement extends for five years from the month when TFDA approval is received. The total value of the agreement to Delcath assuming receipt of the necessary approvals is estimated to be at least $10 million.
The terms of the agreement do not include Delcath providing any drugs used with the Delcath PHP System to Chi-Fu. If during the term of this agreement, other indications for the Delcath PHP System are approved by the TFDA, Chi-Fu will have the right to distribute the Delcath PHP System in Taiwan for those indications as well.
According to Eamonn P. Hobbs, CEO of Delcath Systems, "This agreement is an important first step in bringing our proprietary technology to Asia, where the incidence of liver cancer and related hepatic disease is a major health issue and a leading cause of death. In Taiwan, malignant neoplasms represent 29% of all deaths and as such, we view Taiwan as an excellent opportunity to seek approval to demonstrate the ability of the Delcath PHP System to help patients and improve outcomes. In addition, we look forward to working with Chi-Fu to identify additional indications for our targeted drug delivery platform technology. We believe the Chi-Fu agreement is a significant validation for the Delcath PHP System and we are continuing to pursue additional strategic partnerships to address other key Asian markets," Mr. Hobbs concluded.
According to Wayne Hsu, Managing Director of Chi-Fu and board member of Shing-Er Lii Hsu memorial foundation for the research of medical treatments, "Becoming the exclusive distributor in Taiwan of the Delcath PHP System is key in helping Chi-Fu and the foundation to achieve a number of its goals. Among these goals is our desire to bring innovative technology to the Taiwan medical community, to expand our current product offerings in the oncology segment, and lastly and most importantly, to support the government healthcare system efforts to potentially reduce the death rate and improve the quality of life for hepatic cancer patients. We further see this as the first step in building a strong partnership with Delcath as their platform technology is adapted to treat new cancers and other disease indications in the future."
It has anyways been known that their system was intended to treat extremely rare disease. There maybe few patients, but they do want to live, so price can be negotiate to compensate for a small market. The good thing about percutaneous hepatic perfusion is that it can be used in other indications besides ocular melanoma cause liver cancer. This is especially important in other markets that have less strict rules about usage. For delcath to survive they need to expand into all of these markets. Moving into Brazil is a good step. Back in the day delcath had an agreement to sell to the Asian market under the condition that it get accepted into the us market first. So if they do ever manage to get FDA approved than the whole world will open up to them. This has all been good news for them. The more people they treat the more information they have for FDA even if it comes from outside the US, and their recent deal takes a lot of pressure off fronting the cost of clinical trials. Anyway, that's my opinion on the situation.
Hobbs lied about killing multiple people to the FDA during the early trials and was fired because of it. What the hell are you talking about. He was a scumbag and lost his job. They were sued because of it.
Could you please explain why there are only so many days to sell for tax break? Are they not offering tax breaks next year?
So they cancelled the s1 amendment because there is no longer a need to register securities.
Really big cup and handle forming.
He could have sold and then bought again. That's what I did to recoup my loses. I bought again when it dropped from 10 and plan to do it again... Unless someone has proof of fraud..
I've never heard of a class action lawsuit that was a secret before. Doesn't make any sense, how will they get people to sign up for it?
If no link, what law firm is it?
Link to lawsuit? Anyone? Bueller?
Can you guys post a link to that lawsuit? I can't find anything about it. Like it doesn't exist or something. Hmmm.
I'm pretty sure they are not just going to reach out to me about it, since usually brokers keep investment information private.
Imho, I can see a beautiful cup and handle forming on the daily chart. Porcelain even. Only the finest for Mr. Simpson.
If I could post a photo with this, it would be the one were she is talking to the reporter bedazzled with expensive looking jewellery.
Looks like that trend reversal is happening at least from the charts.
Obviously a long way to go before sentiment reverses.
Again people bashing and pumping are not doing the same thing you are. You continually make extreme actuations of criminal behavior and then make no attempt to back it up. All you say is you should be able to find it.
There are many people paying attention to this stock and no one has posted any actual evidence of fraud or breach if fiduciary duty.
Where is the evidence of these class actions. They usually advertise because it makes them tons of money.
Again with attacks but nothing to back it up. Give an example.
The really funny part is that he is a sales associate for a scammy legal service and he's claiming to be the lead plaintiff. That is pure gold. Sign me up for that job, I want that kind of money to lose.
Very much appreciate your attempt to back up your assertion. One of the few posts on here that's not just pure bashing or libel. Thank you good sir.
Feeling a little hurt that delcath doesn't care about you..
The reality is that there are patients being treated.
At some point you have to face there fact that you just have bad timing with your investments and you can't get over the fact that you lost.
There are other stocks out there that are not trying to help people with cancer.
You guys really need to look at yourselves. Plenty of bad stocks to pick on that won't result in people dying.
How comfortable are you with blood on your hands just to make a buck.
I bought at more $1. Buy low, sell high.
You have totally convinced me of fraud rainy. I'm going to sell my stock and start shorting, so I can damage shareholder value.
How's the rest of the market doing today?
Where did your lead plaintiff go? You know the sale associate for legal shield that lost 100k here? He said he was going to provide information about the class action...
I'm sure that wasn't a lie to try to sell you a scammy legal services, he was very convincing...
Haven't heard from poor rainy either. She never was able to post a single piece of her "evidence".
The old lady is probably too busy threatening people on here and then deleting the posts.
You guys get so quiet when this is doing well. You just hate to see this go up.
Loaded up big time since yesterday. Thanks guys for all your help. Keep that information and facts coming.
I'm sure you'll all get your bankruptcy and lawsuits and whatever it is your goal is here.
I'm in it for the money.
Holding itself up pretty well despite a terrible day in the market.
Why can't you just post one piece of evidence?
I really don't understand what the hold up is.
You have claimed repeatedly that it is so easy to find fraudulent evident, but you still haven't pointed to anything specific.
What is the evidence. Please show me the way...
I'm not asking to be convinced. I'm asking you to post your evidence of fraud. It's not a matter of opinion. I'm asking you to show me what you believe to be fraud. What are the facts?
That's all I want to know, what evidence do you believe is fraud?
Fraud is a really serious allegation, it's not the same as making a bad investment.
If you have evidence of fraud share it so we can take down this company.
It really makes no sense to withhold that information.
If you know anything about ethical shorts, you would know that they try to share information publicly to try to take down the company. It makes no sense that you are being secretive about it.
I want to find out more about being a legal shield sales associate also. Looks like a fun gig...
For the record, no one on the this forum has even attempted to provide any information regarding their "lawsuits" or fraud claims.
I've only been met with attacks and threats on this forum. Some members are saying they are collecting my information and doing an investigation on me for questioning their information.
I'm appalled that the moderators have done nothing about this. Moderators are allowing threats against other users to continue on this board. The moderators have also done nothing about the libel that is posted by a few members on here.
My brother, the lawyer, is offering you free council if you can post one piece of evidence of fraud here. I will even help pay for an investigation.
Should be really easy to do, right?
I feel like you guys are just not reading my posts. I'm asking you guys who keep claiming that you are currently suing this company to prove it. Provide any evidence of fraud and I'll stop asking for it.
I'm an investor, if there is fraud happening here, I want to know about it.
HB and the gang are trying really hard to dominate this forum. There are much better sources of information about this ticket out there if you are looking for unbiased not non-manipulative information.