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   Biotech / MedicalImmunomedics (IMMU) - moderated


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To: patlawche11 who wrote (52231)9/23/2019 1:46:33 PM
From: patlawche11
11 Recommendations   of 58475
 
Ascent now shown at Clinical Trials as Active, not recruiting. No surprise, but interestingly, 529 participants were actually enrolled vs. 488 that were previously estimated.

clinicaltrials.gov

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From: sysiphus9/24/2019 6:50:54 AM
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nature.com

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From: JJINV9/24/2019 5:42:46 PM
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Pretty darn close today..


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From: stockdoc779/25/2019 12:08:40 PM
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Biotechs weak last few days, any particular reason?

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To: stockdoc77 who wrote (52516)9/25/2019 2:33:16 PM
From: bobbseytwins2001
1 Recommendation   of 58475
 
Ascendence of Elizabeth Warren in the polls is considered a possible move toward "medicare for all", which market takes as a possible threat to healthcare stocks.

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To: stockdoc77 who wrote (52516)9/25/2019 3:04:07 PM
From: Fitzhughlaw
5 Recommendations   of 58475
 
Pharma companies being demonized by both parties about "high" drug prices, and surprisingly enough, both Pelosi and Trump are considering some of the same "solutions" to lower them. One is having the government negotiate directly with "big pharma" over what it will pay for drugs paid for by Medicare and Medicaid. From a Forbes article that's two weeks old: "All 10 Democratic candidates for president who’ve qualified for the debate on Thursday, September 12 have voiced support for various pieces of legislation to lower drug prices. Some of their ideas even align with proposals from President Donald Trump, including letting Medicare negotiate drug prices with pharmaceutical companies. And all would take some freedom away from drug makers for setting, and changing, prices." forbes.com

Another of the proposed "solutions" that has been getting more traction lately, and which I find particularly disturbing, is an "international price index" that would peg prices here in the US to what other countries charge. However, many, including all EU members, strictly regulate what can be charged, so if something akin to that were implemented here, there would be de facto price controls. An NPR article from last week points out that those are indeed some of the countries being heralded as examples for setting the index. I've reproduced part of it below, along with a link to the entire piece; notwithstanding it's obviously left-leaning slant on the issue, I found it accurate in reporting the seminal fact that proposals like that are coming from both sides of the political spectrum, and with similar language; Pelosi talks about drug companies "ripping off" Americans, and Trump saying "They've taken advantage of us for a long time." Thus, it's easy to see why investor interest may be tempered. As the article states in part: "Both plans would use the average price internationally for each drug as a benchmark in negotiations, so that Americans don't pay more than about 20% above what people in other countries pay. That's still more than what people pay outside the U.S., but less than they pay now."

Of course, looking on the bright side, Immunomedics shareholders don't have to be concerned about that yet, because Behzad and the rest of our great leadership team blew the biotech opportunity of a lifetime by ensuring that rinky-dink Morris Plains headquarters was the only facility on the face of the Earth that would manufacture HRS7 - and therefore for want of a simple compound that's not even under patent protection anymore, over a hundred million dollars in "sunk costs" have been squandered and which will never be recouped, billions in shareholder value was destroyed, and thousands of women have needlessly suffered. Thus, we have great data, but no product to sell - but hey, the upside is that we have no worries about the effect of price controls! Who says I'm not a "glass half full" kinda guy? But I digress. Herewith more excerpts from the article:

How An 'International Price Index' Might Help Reduce Drug Prices

In gridlocked Washington, both Democrats and Republicans have signaled there's potential for a deal when it comes to lowering prescription drug prices. Now, there's an idea both Congressional Democrats and the White House seem to like: They want to base U.S. prices on something called an international price index.

"The basic idea is to peg what the United States pays for a particular drug to the price paid in some set of other countries," says Rachel Sachs, an associate professor of law at Washington University in St. Louis who specializes in drug pricing policy. "There are many different ways to identify other countries, and there are many different ways in which that international reference price could be used to negotiate for a price here."

House Speaker Nancy Pelosi unveiled her sweeping plan to reduce drug prices Thursday, which included an international price index. There are lots of differences between that plan and the one the White House floated last fall, but the basics — and the appeal of the concept — are the same.

"It stops drug companies from ripping off Americans while charging other countries less for the drug," Pelosi said in a press conference announcing the House plan, which would use drug prices in Australia, Canada, France, Germany, Japan, and the United Kingdom to create a baseline in negotiating prices.

She's speaking President Trump's language. Here's what he told reporters in July: "Why should other nations like Canada — why should other nations pay much less than us? They've taken advantage of the system for a long time, pharma."

Earlier this summer, the Department of Health and Human Services sent its own IPI proposal to the White House for review, though the details haven't been made public. The idea of establishing an IPI is the only element of the administration's plan to lower prescription drug prices still on the table — other ideas, like displaying list prices in TV ads and ending secret rebates for middlemen have been withdrawn or blocked in the courts.

Unsurprisingly, drugmakers also object. "Speaker Pelosi's radical plan would end the current market-based system that has made the United States the global leader in developing innovative, lifesaving treatments and cures," Stephen Ubl, CEO of lobbying group PhRMA, says in a written statement. "We do not need to blow up the current system to make medicines more affordable."

But Pelosi and her allies seem to be betting there is political will to go against drugmakers this time. Despite the huge sums spent on lobbying, the pharmaceutical industry is now the most unpopular industry in the country, according to a recent Gallup poll. And with a presidential election coming up, Americans polled say lowering drug prices is a top priority.

Full article: npr.org

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To: Fitzhughlaw who wrote (52518)9/25/2019 3:23:56 PM
From: urslor
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I have a feeling we are not being told something important....

Seems like to big a drop on speculation related to a possible price regulation in the future when we don't even have a drug for sale yet.

doubt the new trolling lawsuit has caused any drop

ergo ..shorts again??

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To: urslor who wrote (52519)9/25/2019 4:01:23 PM
From: Fitzhughlaw
7 Recommendations   of 58475
 
I didn't mean to imply that all of the weakness in the PPS was due to the specter of price controls, merely that sector weakness is occurring. Immunomedics has always outperformed on the downside whenever there's a biotech sell off. Some have suggested that the company will use the impending investor event in Barcelona to backpedal on a resubmission filing date, but I don't know if that's an item of widespread concern. As to your idea, it could indeed be the shorts, and one scenario is that they are trying to push down the price ahead of what should be good data about to be released in Barcelona in about 72 hours.

However, we shouldn't even have to be concerned about short sellers. Don't mislead your shareholders and torch the analysts who support you by screwing up the one thing you promise you'll do (be competent), and the shorts will be rendered irrelevant. A lesson that for the life of me I cannot understand Behzad and the BOD failed to grasp a year ago.

In addition to great data, I am hoping for clear and unequivocal guidance on resubmission by a date certain. It has to be the foremost question on every analyst's mind, and trying to dance around it would be [another] huge mistake. After almost 9 months of fixing what should have been done correctly the first time, investors will have no patience for anything less than a firm commitment to a filing date.

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To: urslor who wrote (52519)9/25/2019 4:07:27 PM
From: JohnBeach
1 Recommendation   of 58475
 
The 4th quarter is next week. Resubmission of the BLA has been promised to occur in early 4th quarter. The Venbio team doesn't have a record of success, in fact outside of maybe the Everest deal, there is not a single success that can be credited to them in nearly 3 years of control. All of the clinical success, including the data that will be revealed on Saturday, was already on rails when they took over. So it will be no surprise when Behzad tells us on the call Saturday night that they have failed to meet the commitment and they will be submitting in Q1. I think that's why we are selling off. Low expectations based on a record of failure.

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To: JohnBeach who wrote (52521)9/25/2019 4:25:31 PM
From: duwhee
6 Recommendations   of 58475
 
You forgot the Royalty Pharma deal and the recent deal to sell shares at a price per share the G's never would have gotten.
In my view, all the money we have in the bank now to tide us through and over is because of the VenBio crew.

If the G's had chosen to advance 132 alone, I can't help but think they'd have missed with the FDA as well, AND we would have had to undergo huge dilution just to buy enough fumes to get us to the resubmission

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