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Overreacting to Gilead's Coronavirus Drug Remdesivir
Barrons ^ | Friday, April 17, 2020 | Josh Nathan-Kazis

Posted on 04/17/2020 12:30:04 PM PDT by SunkenCiv

Investors may be too enthusiastic about a scoop from the health-care news website STAT on a trial of Gilead Sciences’ antiviral drug remdesivir in patients with severe Covid-19, analysts say.

Gilead (ticker: GILD) shares were up 10.6% shortly after the open on Friday, and had risen much further in trading after the close on Thursday. STAT reported Thursday evening that nearly all of the patients at one Chicago hospital participating in a Gilead-sponsored trial of remdesivir were discharged in less than a week.

The S&P 500 and other major stock indexes rallied in response to the news, as well as President Donald Trump’s Thursday announcement of guidelines for the reopening of states’ economies.

Investors are waiting on results of a handful of large, randomized trials of remdesivir, the first of which are expected any day. The STAT report isn’t data from the trial, but rather a positive anecdote from one trial site. Yet the stock’s moves were as dramatic as those analysts had expected might result from a positive trial readout.

“We would have thought that kind of reaction would have been reserved for positive clinical trials,” wrote Cantor Fitzgerald analyst Alethia Young. She wrote two weeks ago that the results of a trial would likely move Gilead stock 10% to 15% in either direction.

Hints about remdesivir’s efficacy have been coming in drips in recent days. On April 10, the New England Journal of Medicine published data from hospitalized Covid-19 patients given remdesivir on a compassionate-use basis that appeared to be positive.

(Excerpt) Read more at barrons.com ...


TOPICS: Business/Economy; Politics/Elections
KEYWORDS: coronavirus; gilead; remdesivir
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1 posted on 04/17/2020 12:30:04 PM PDT by SunkenCiv
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To: AdmSmith; AnonymousConservative; Arthur Wildfire! March; Berosus; Bockscar; cardinal4; ColdOne; ...
...

2 posted on 04/17/2020 12:30:37 PM PDT by SunkenCiv (Imagine an imaginary menagerie manager imagining managing an imaginary menagerie.)
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To: SunkenCiv

From the Shawshank redemption:

“Remember, Red, hope is a good thing, maybe the best of things...”

And I have hopes for this drug because it has a clearly understood mechanism of action over a variety of viruses.

I have hope for HCQ/Zinc/Z-pak, too.


3 posted on 04/17/2020 12:33:57 PM PDT by Pearls Before Swine
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To: SunkenCiv

WELL WHY STOP OVERREACTING NOW?????

/SARC


4 posted on 04/17/2020 12:38:11 PM PDT by Secret Agent Man (Gone Galt; Not Averse to Going Bronson.)
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To: SunkenCiv
Hopefully, we won't repeat this every year, and the drug won't be needed every year. Unlike Tamiflu.

(Full disclosure: I own stock in the company and like it, but not only because of remdesivir.)

5 posted on 04/17/2020 12:38:44 PM PDT by Sooth2222 ("Every nation gets the government it deserves." -Joseph de Maistre)
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To: Pearls Before Swine
If it turns out that the HCQ trio of cheap drugs works well early in the treatment of the C-virus, why would doctors wait until the patient is much sicker, needing oxygen, even intubation when perhaps the much more expensive drug works better? That makes no sense to me.

How about use the HCQ trio early but, if it doesn’t work, then go to the other one. Does it have it be only one of them?

6 posted on 04/17/2020 12:40:55 PM PDT by Freee-dame
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To: SunkenCiv

Sometimes you can hit it drawing to an inside straight,
...
...
...
...
, but I wouldn’t go all in on it.


7 posted on 04/17/2020 12:41:44 PM PDT by budj (Combat vet, 2nd of three generations.)
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To: Freee-dame

Treating COVID19 in hospital is 13,000.00 from Feds and ventilator hospital treatment is 38,000.00 reembursed via Fed dollars, so you guess when the real time to save treatment will likely start. Sounds horrible but the incentive is there!


8 posted on 04/17/2020 12:51:20 PM PDT by gbs
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To: gbs

That is even worse than I had thought.


9 posted on 04/17/2020 12:52:28 PM PDT by Freee-dame
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To: Freee-dame

Exactly.

Cure the patient what ever it takes.

Also everyone wear masks, wash your hands, practice reasonable social distancing and lets all get back to work.


10 posted on 04/17/2020 1:03:45 PM PDT by desertfreedom765
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To: Freee-dame
Does it have it be only one of them?

Of course not.

I'm just speculating, given some of the reports out there, that HCQ and friends works better if given early. Quick turnaround tests may make that possible.

Remdesivir attacks viral reproduction, pretty much stopping in in its tracks. THere have been some cases where it worked on people who were in rough shape, intubated, with a high viral load and other sorts of damage, who were brought back with its use.

Could both be used sequentially if necessary? I hope so!

11 posted on 04/17/2020 1:10:05 PM PDT by Pearls Before Swine
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To: SunkenCiv
As far as I can tell, this drug is administered intravenously and requires hospitalization of up to 10 days with no problems.

While a suggested cost is $1000....if it's per unit and one unit per day....this could be a $10,000 cure.

I wouldn't put all my eggs in this basket.

The Malaria cocktail is $20 for the entire workup....with no hospitalization.

12 posted on 04/17/2020 1:13:10 PM PDT by Sacajaweau
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To: Sacajaweau; SunkenCiv

RE: While a suggested cost is $1000....if it’s per unit and one unit per day....this could be a $10,000 cure.

I Have seen this number, $1,000 being thrown about, but I can’t find a reliable reference for it.

Can you show us where you got this figure from?


13 posted on 04/17/2020 1:24:15 PM PDT by SeekAndFind (look at Michigan, it will)
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To: Pearls Before Swine

We had a 91 year old, frail family member (with multiple existing other health issues) contract COVID19 to the point of extreme shortness of breath, get treated with Hydroxychloroquine, and go home from the hospital < 1 week later.

Not to say it “always” works, but it sure seemed to in this case.


14 posted on 04/17/2020 1:25:06 PM PDT by jstolzen
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To: SeekAndFind

I read it just like yourself....BUT I believe the company had not disclosed any price.


15 posted on 04/17/2020 1:29:01 PM PDT by Sacajaweau
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To: Pearls Before Swine

Yes, HCQ + zinc is effective if given early. They can be freely prescribed since already approved by the FDA. Once the patient goes into the ICU, right to try might enable doctors to give the Remdesivir. 15,000 C-19 patients in ICU now. That could be an immediate market for Gilead.


16 posted on 04/17/2020 1:34:19 PM PDT by Qout
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To: SeekAndFind

Just read a little more...There is no control group for Gilead’s testing.


17 posted on 04/17/2020 1:38:40 PM PDT by Sacajaweau
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To: Qout

Freely prescribed if your doctor, or your hospital will do it.

I’m on Cape Cod, and they were doing a good job about testing and providing some info, but the last I read the head infectious disease doctor was very “ahem”, cautious about HCQ.

As for remdesivir,it sounds to me like you won’t get it early. And, I’m not sure where you have to be, or who your doctor has to know, to get it.

The law isn’t a block, but inertia (in the case of HCQ) and access/supply (in the case of Remdesivir) may be. Depending, on where you are and who you know.


18 posted on 04/17/2020 1:39:08 PM PDT by Pearls Before Swine
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To: SunkenCiv

btw, that NEJM article that Gilead had published was totally shredded by professional researchers, one researcher’s conclusion was that the data were “unintelligible” ...

also, it’s good to note that serious medical professionals refer to NEJM as the “Ladies Home Journal of Medicine”

basically, the NEJM article was nothing but a means to fluff Gilead’s sinking stock ....

here’s some of the shredding:

from a medical website:

New data on the investigational antiviral drug remdesivir (Gilead) suggest clinical improvement in 36 of 53 patients (68%) hospitalized for severe COVID-19, according to a new study published online April 10 in the New England Journal of Medicine.

But experts are warning that these data come from compassionate use in a wide variety of patients, with no randomization and no control group.

“It is impossible to know the outcome for this relatively small group of patients had they not received remdesivir,” commented Stephen Griffin, PhD, associate professor at the University of Leeds School of Medicine, United Kingdom, who was not involved with the study.

“As the authors point out, a randomized clinical trial is necessary to determine the true effectiveness of this drug,” Griffin added in comments he provided to the Science Media Centre in London. Such trials are underway. The data from this paper are almost uninterpretable. Prof Stephen Evans, London School of Hygiene & Tropical Medicine

“The data from this paper are almost uninterpretable,” said Stephen Evans, MSc, FRCP, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who provided comments to the Science Media Centre.

Evans notes that the authors describe multiple caveats that limit interpretation of the results, including the small sample size, the relatively short follow-up, missing data, no follow-up on eight patients, and lack of a randomized control group.

Meanwhile, Josh Farkas, MD, who writes the PulmCrit blog, details his criticisms in a piece entitled, “Eleven reasons the NEJM paper on remdesivir reveals nothing.” Beyond the issues the authors list, he points out several more, including cherry picking of patients. “Remdesivir was aggressively sought-after by thousands of patients with COVID-19,” he writes. “Of these patients, 61 ended up receiving the drug. Why did these patients receive medication, out of scores of patients applying to receive it?”

Also, there are no follow-up data for 8 of the 61 patients who received an initial dose of the drug, leaving 53 for the published analysis, continues Farkas, who is an assistant professor of pulmonary and critical care medicine at the University of Vermont in Burlington.

“What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown — but I’m worried that these patients actually didn’t fare so well,” Farkas writes.

Farkas, like Evans and Griffin, concludes that the data are largely unusable. “Until [a randomized controlled trial] is performed, further compassionate use of remdesivir probably isn’t justified,” he writes.

and more:

“Eleven reasons the NEJM paper on remdesivir reveals nothing”

https://emcrit.org/pulmcrit/pulmcrit-eleven-reasons-the-nejm-paper-on-remdesivir-reveals-nothing/

https://twitter.com/hashtag/PrimumNonNocere

commentary on NEJM:

https://twitter.com/NEJM/status/1248697013870493698

“I want to cry looking at this paper”

https://twitter.com/sgdambrauskas/status/1248731936681590785

here’s some comments about the NEJM article from doctors commenting about it on medscape:

“I question the double standards and intent - no controls, only 53 pts (63-8 excluded suspiciously) scattered over 3 CONTINENTS (so management variable to say the least) and 68% improvement in oxygen score (when 50+% expected to improve on their own) - this gets published in NEJM - gets promptly hailed by Gilead CEO and media. GLD stock had lost 10% over the month after initial hype, it’s anyone’s guess what will happen next. All this while the academics are criticizing HCQ ad-nauseam because it showed 97% pts improved in a poorly controlled trial of 1061 pts conducted by one person.

We don’t know if it will be HCQ or Remdisivir or something else, but can we quit double standards and think of sick and dying patients first?

Why even talk about 53 pts when USA alone has half a million?

What is happening here? “

and another:

“The problem is that Gilead failed to include enough patients in the trial. Their methodology completely eludes me. This drug may very well be as good or better than Hydrochloroquine, as it went through all trials and approval in the past for Ebola, though it was not that effective for that virus.

I question if it is politics here, or just blinders-on overlooking it by the FDA, CDC, or Dr. Fauci, that they have shown but a fraction of the interest in Remdesivir than it did in HC.”


19 posted on 04/17/2020 2:02:05 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: Qout

“Yes, HCQ + zinc is effective if given early.”

I keep hearing that. I have not doubt that it works better when given early. But the truth is that several doctors have given it late in the game when things looked rather hopeless. And it did save lives even then. Some of those people were around 100 years old. And one even had heart problems.


20 posted on 04/17/2020 2:10:41 PM PDT by Revel
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