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Agreed. I don't see how Gottlieb could possibly be correct that the pandemic will be over in 2 mos. Pfizer's drug won't even be widely available until early next year, and even then, at best (and there's good argument that this is a bit skewed) it's 89% effective if taken early. Detla's symptoms early on are like the flu. How many of the approximately 50% of the country who refuse to be vaccinated will be willing to take another "experimental" treatment for mild symptoms, of what many will refuse to believe is Covid, and those who do, believe they'll survive it, anyway? I fear we're a long way off from being rid of this scourge. At best, with more getting vaccinated and various treatments (including, hopefully, B), it will become something manageable we can live with.
I don't mean to be disrespectful, but I don't see on this woman's FB page
(https://www.facebook.com/christine.bandyhelderman/posts/1943496145814218) any update that her "congregant and friend," Judy has died. It's unclear to me that the poster is Jewish - she posts more about church - and since Judy is a congregant, she may not be, either. So, the posting of "Meditations before Kaddish" (and note, this is not a translation of the actual Kaddish, itself) may have nothing to do with Judy. It may just be something the poster has recently become aware of as this was posted during the Jewish High Holy Days and the Mourner's Kaddish is said in Temple every Sabbath and every High Holy Day - it is not specific to or necessary that someone died for it to be recited. It is also said by mourners on every anniversary of a death.
What are you and Minnesinger talking about? You really think people are enrolled in a trial without being told upfront they'll get either placebo or the drug? Perhaps your reading comprehension is faulty. They are not told which one they will get, just that they will get one or the other. Not telling them would be totally unethical. It's called informed consent.
Sheesh.
But, they are told that they'll receive a placebo or B. You said they were not.
You must have misunderstood the question. Of course, they are told. They have to consent to be in the trial. They are told that they will definitely get R, but that half of them will get R+Placebo and half R+B. They and the treating physicians do not know who gets what until it's unblinded at the end. The patients can refuse to be in the trial and opt to just get R.
Science evolves as more data is obtained. That's why we didn't consider treating Covid with leeches and blood letting.
Agreed. It makes sense that the FDA has these safeguards in place to avoid even the appearance of impropriety. If a drug has even the slightest chance of eventually being FDA approved (as all P2 drugs do), one would think the FDA would want to ensure that no one in its organization would be tempted to do anything to aid or impede the drug's trial progression because of their own monetary gain.
Another promising therapeutic, in an inhaler:
https://www.timesofisrael.com/new-israeli-drug-cured-moderate-to-serious-covid-cases-within-days-hospital/
We will need more than one treatment to fight this virus. Even the preliminary study with hydroxychloroquine showed a cure rate of 70% and it's unclear, since asymptomatic patients were treated in the study, if there was a difference between cure rates in the most seriously ill or the least. You never want to be limited to only one treatment for serious illnesses. Best if there are several to chose from.
Vitals.com? Oh, please. That website and Healthgrades list docs and their addresses/phone numbers based on public info. Docs have been screaming bloody murder about this for years, as sometimes they'll even list home addresses/phone numbers if they can find them. The listings are almost always involuntary from the docs' perspective. Means nothing.
ClayTrader did NOT say that. He said, "I'm not saying the price is going down to .28. I just want to illustrate just how strong the overall chart and trend currently is." He used the words "bullish" and "strong" (as in uptrend) multiple times. (And BTW - yesterday he said if .32 held, that would be extremely bullish, but he was even bullish even if it did not.)
It's fine to be negative - certainly we all have reason to be with this stock's history - but enough with the spin, fake news and alternative facts.
Any time a doc prescribes any med for anything, the doc is supposed to give the patient informed consent, which would include discussion of potential side effects, alternative treatments, no treatment, etc. If the drug is being used off-label, that fact is also supposed to be included in this discussion. The doc documents he/she had this discussion with the patient in the patient's chart.
I don't do patient care anymore, but when I did and I prescribed something off-label, I can't recall a time where a patient balked at a med for that reason. I truly just don't think off-label use is a big deal, especially for a drug with minimal safety concerns.
If you were a patient getting treatment for cancer and were told about the horrible side effect of OM, and then were told that there was a proven, FDA-approved treatment for it that had a decent chance of even preventing it in the first place, was easy to take, but had only been formally approved by the FDA for a different cancer, would you really care?
I'm also a senior medical director for an insurance company. As for insurance not paying for off label use, that is often true at first, but as the drug becomes more widely prescribed and accepted off-label, insurances very often will, especially when there isn't something being used that is just as good/cheaper.
In the case of B, since there would be nothing comparable that can possibly PREVENT the occurrence of OM - which remember, would be a VERY costly side effect for an insurance company - I suspect that insurances would adopt paying for this quickly in off label uses.
As for the FDA letting docs prescribe off-label whenever they want: Remember, approved meds have already gone through extensive safety testing to get where they are. If something comes up after approval, a drug can then be pulled - or not. An example of not, even in what appears to be an extreme case is some antipsychotics used in psychiatry. It's been discovered over the years that a rare side effect in the elderly can be sudden death (due to cardiac issues). The FDA has not pulled these drugs because they are so beneficial in many populations, but rather has added a "black box warning" to them, specifically warning of this side effect in this population. But, even that doesn't mean a doc is prohibited from prescribing these drugs in the elderly, and many still do. It just means that in addition to informing the patient/family that this is an off-label use, the doc has to also inform them of the black box warning, so they can make an informed consent decision.
Neurontin is also prescribed off-label for sleep and as a mood stabilizer in bipolar disorder.
Speaking of which, Depakote, also originally an anti-seizure med, is now very widely prescribed off-label as a mood stabilizer in bipolar disorder.
I'm a doc. Off-label use is done all the time for a variety of drugs. The only way the FDA would get involved in off-label use is if the use of the drug for an indication other than that for which it were approved, proved dangerous. Hard to imagine that would be the case, here.
Also, once oncologists, hospitalists and primary care docs (who will still be caring for their cancer patients) see that B not only mitigates, but can prevent this awful side effect, they will certainly start prescribing it for their other cancer patients undergoing similar treatments with the potential for OM. Cancer patients themselves and their families in support groups, or talking/meeting each other in outpatient oncology offices or cancer wards, would start demanding it. Docs will publish studies in various journals studying B and OM in other cancers, totally separate from having to do another FDA trial.
If B gets approved for this one indication, I really would not worry at all about its not being prescribed for others.
Biohedge, why do you think there was no deal after B's incredibly successful P2b B-ABSSSI trial?
I've been in CTIX/IPIX since it was 0.53 years ago, have never sold a share, and have continued to accumulate. I'm a doc, and I very much understand what I own here, but the lack of any kind of deal after that success continues to puzzle me.
Despite all the enemas, it is telling that none of the patients dropped out of the study, which of course they would be free to do at any time (note that one refused endoscopy at the end). This speaks to how awful the disease is, as well as their feeling that the hassle of all those enemas was worth the benefit they were receiving.
Positive article on CTIX: https://www.insiderfinancial.com/markets-have-missed-an-opportunity-in-cellceutix-corp-otcmktsctix/120290/
Sorry, have been offline a few days. Don't know if this was posted previously,
Antibiotic Apocalypse - Great blog post from an Emergency Dept doc, summarizing this issue with links to articles. His blog is widely read, BTW.
http://drwhitecoat.com/antibiotic-apocalypse/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+drwhitecoat+%28DrWhiteCoat%29
The C word: Nov 15, 2016 was the first mention of CDAs. Leo said in that Q1 Fiscal Update call, "We maintain ongoing discussions with multiple potential corporate partners and also continue to develop new relationships. To that point we have signed CDA's with some of the world's largest pharmas and biotechs."
Again, while we heard there was "interest" or "discussions," we'd never heard the C word, before.
"why a year for peer review for a journal" - it's very very rarely any less than than, often more. The best, more desirable journals (which it is likely Dana Farber would submit to) get hundreds of papers submitted. Most of these journals publish monthly. Once the editors sort through all the submissions to find likely prospects, they have to contact several peer reviewers in the same field to see if they are available to do the reviews. These are most often busy docs/researchers. They don't drop everything to review articles. They would likely get months to respond. They will have questions/comments that then go back to the author to address and rewrite. An article NEVER gets published without some back and forth. Then, the graphs, data etc has to be evaluated and checked. Once everything is done, and the paper edited to conform to that particular journal, they would set a pub date.
This is a very, very long process. A year is nothing to be concerned about.
Any law firm would be extremely foolish to file a suit based on Mako's latest hit piece, given what happened to Rosen based on Mako's first one. And, note: out of the many, many law firms that sent out notices piling on after Mako/Rosen, only Rosen ended up actually getting a plaintiff, and then only ONE.
That we are only down less than 8% today after this latest crap, really indicates investors, on the whole, now understand what is true and what is not. Mako was certainly encouraged by the havoc he created after his first hit, but he and others may not be so inclined again given the relatively tepid reception today.
I have already filed complaints as per Baron4664's instructions, after the first hit. We all need to do so, especially to the Investor Protection Bureau and the NYAG. Mako even being preliminarily contacted by any agency about this is another way to stop him before a partnership.
Don't click on the article. That only causes it to trend on Seeking Alpha, getting more views. Perhaps someone can summarize it, or if you're reading it now, cut and paste?
Can someone post in the comments on this new Mako hit piece the judges dismissal with prejudice of the Rosen lawsuit and say that it was entirely based on Mako's previous hit piece which was completely refuted, contrary to what this new hit piece says? There are no comments now on this new Mako piece, so nothing he says is being refuted.
Listen to the call. The market has misunderstood the label issue. First of all, the drug that was granted exclusivity for nasal is NOT EVEN BEING SOLD YET. It is expected to hit the market in the next few months, ie later than Arymo which is shortly going to hit the ground running. EGLT already has all the marketing and contacts in place with prescribers, due to their pipeline. Additionally, Arymo is labeled as abuse deterrent for IV (the worst, most deadly form of abuse that docs care the most about) and the evidence for nasal deterrence is public domain, and can be used by the company in marketing to docs, even if the label doesn't say it. Docs (and I am one, so I know) can and do prescribe drugs "off label" all the time. It is no big deal. And, this isn't even an off-label use. If anything, I'd call it an off-label benefit. EGLT management also made the point that multiple states have passed laws that insurance companies must give equal weight to these abuse-deterrent drugs. If you're a doc and you want to prescribe an abuse deterrent drug, you're going to go for the one with the widest, proven reach, ie nasal and IV. It won't matter at all that the label itself can't include nasal until Oct 2, 2018. Oh, and only Arymo is OK with alcohol. Alcohol + opiates is even more deadly than opiates alone. Docs are very concerned about this, even absent the addiction issue. If this dips tomorrow, that will indicate to me that the market just does not understand any of this, and I will be a buyer. One more thing - the Guardian technology is not a one-off on just Arymo. Think about that given the massive public health issues of opiate addiction that are getting more and more press and government scrutiny.
And, Seeking Alpha, after all the complaining emails, still chose this latest Mako hit piece as an editor's pick. Whenever I try to post a comment on any of Mako's "reports," politely questioning Mako's credibility, SA removes it.
Mako = Pump Stopper theory from another poster on Aug 2015:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=116165363
I like the theory that Rosen is not confused at all, just careless.
Let's get the word out to reporters by scanning bylines of healthcare reporters for major business newspapers, magazines and online sites such as WSJ, biz section of NYT, CNBC etc. It's easy to find the reporter's contact info. Send them a brief email about this case, that the SEC, NY State Attorney General are looking into it, Ashcroft Law Firm is involved, etc. If we can pique the interest of one reporter, the publicity for CTIX (and against Rosen) will be tremendous.
Duh. There were other posters here who also said they were going to report Rosen and Kim to the disciplinary committee. Anyone else?
Sanctions vs. Rosen/Kim possible now.
This letter was sent to me by the Chief Counsel of the Dept Disciplinary Committee, Supreme Court, Appellate Division, First Judicial Dept on 12/11/15, a few months after I filed a complaint against Rosen and Kim:
"As you know, there is pending litigation concerning allegations which are substantially similar to the material allegations of professional misconduct you have alleged here. In particular, the pending suit in the United States District Court, Southern District of New York, involves issues directly related to the substance of your complaint. We have found that a judicial determination of such matters is helpful to the Committee. Accordingly, we have determined to defer further investigation at this time. Please inform the Committee of any court decision or other event which may warrant immediate investigation. In addition, the Committee will periodically take steps to ascertain the status of the litigation. The Committee will notify you if it determines at a later date to re-activate the investigation."
Dismissed WITH prejudice. Nice.
There is going to be a paper published in a scientific journal. That's how Dr. Shapiro will tout it. We were told a paper was submitted in a PR sometime in the Fall, I believe. Getting papers published in scientific journals can take around a year after submission.
If K data was bad, I doubt Dr. Shapiro would have submitted a paper on it. Touting trial results prior to the paper being published can jeopardize its getting published. Scientific journals are just like any other magazines, newspapers, etc in that regard: they want scoops.
Getting papers published in peer reviewed medical journals can take at least a year after first submitted. Many of these journals are monthly, so their content is set for several months in advance. Several peer reviewers look at each paper, and a paper that is submitted is never published as is. There are always edits and back and forth. I would be surprised to see the paper published before this Fall.
Shapiro's time and that of his fellow researchers, research assistants, techs, labs etc etc are finite. If he didn't think there was a there there, he would have long ago moved on to something else. His goal in life is to cure cancer and publish big deal papers (and maybe head the NIH :). He's not going to waste precious time and resources on a dead end.
I thought several of us sent packets to the Departmental Disciplinary Committee of the Supreme Court, Appellate Division in NY. Several of us said we did after Barron provided the info on how to do it.
I disagree to wait until after the litigation. The first communication I got back from them was a postcard dated 10/1/15 (many, many weeks, if not months, after sending my packet) and it said they get such a large volume of complaints, this all may take a lot of time. I got the second communication, a personalized letter last week, saying they will wait until the current suit is done.
I think complaints will have much more impact if there are several/many all at one time. If you wait until the suit is settled, the Committee may not even realize there are more complaints until after they actually look into the one I sent.
This is a very, very slow process, as they said in their first, standard, non-personalized postcard, "due to the large volume of complaints filed."
I got letter from Disciplinary Committee. They are waiting on the outcome of the Rosen suit before considering this. Anyone else hear back?
While spelling your name wrong. More sloppiness on their part.