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GBT (+37% /PM) Announces U.S. FDA Agrees with its Proposal Relating to Accelerated Approval Pathway for Voxelotor for Treatment of SCD and GBT Plans to Submit NDA
https://www.streetinsider.com/dr/news.php?id=14883087
It seems they are one and the same.
Extensive stage small cell lung cancer is defined as the stage during which the cancer has metastasized (spread) to other parts of the body, such as the lung or brain. The liver, adrenal glands, and bone are also common sites of metastasis.
BMY Announces CheckMate -451 Study Did Not Meet Primary Endpoint of Overall Survival with Opdivo Plus Yervoy Vs. Placebo as A Maintenance Therapy in Patients with Extensive-Stage Small Cell Lung Cancer After Completion of First-Line Chemotherapy
https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-checkmate-451-study-did-not-mee
CRISPR inventor Feng Zhang calls for moratorium on gene-edited babies
https://www.technologyreview.com/s/612465/crispr-inventor-feng-zhang-calls-for-moratorium-on-baby-making/
The Chinese scientist who claims he made CRISPR babies has been suspended without pay
https://www.technologyreview.com/s/612466/the-chinese-scientist-who-claims-he-made-crispr-babies-has-been-suspended-without-pay/
#CRISPR gene-edited baby story update from Chinese media
— Andy Biotech (@AndyBiotech) November 26, 2018
He Jiankui's University "unaware of the research project" and will immediately launch an investigation.
Shenzhen HarMoniCare Hospital denied any involvement in the project
IRB approval questioned, signature likely forged pic.twitter.com/nThN7780iP
Chinese scientists are creating CRISPR babies
https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/
A daring effort is underway to create the first children whose DNA has been tailored using gene-editing.
...
According to Chinese medical documents posted online this month, a team at the Southern University of Science and Technology, in Shenzhen, has been recruiting couples in an effort to create the first gene-edited babies. They planned to eliminate a gene called CCR5 in order to render the offspring resistant to HIV, smallpox, and cholera.
...
The birth of the first genetically tailored humans would be a stunning medical achievement, for both He and for China. But it will prove controversial, too. Where some see a new form of medicine to eliminate genetic disease, others see a slippery slope to enhancements, designer babies, and a new form of eugenics.
...
The genetic editing of a speck-sized human embryo carries significant risks, including the risk of introducing unwanted mutations into it or of yielding a baby whose body is composed of some edited and some unedited cells. Data on the Chinese trial site indicate that one of the fetuses is a “mosaic” comprised of cells which had been edited in different ways.
They are surprisingly good at predicting these things. Here’s another one:
https://futurism.com/videos/these-robotic-bees-are-straight-out-of-an-episode-of-black-mirror/
Indeed. I would recommend Black Mirror Season 3 Episode 1 on Netflix if you haven’t already seen it.
https://www.esquire.com/news-politics/amp19467976/black-mirror-social-credit-china/
Texas Is About to Create OPEC's Worst Nightmare
https://www.bloomberg.com/news/articles/2018-11-21/opec-s-worst-nightmare-the-permian-is-about-to-pump-a-lot-more
Genfit plans US listing as NASH drugmakers race to the finish line
https://endpts.com/genfit-plans-us-listing-as-nash-drugmakers-race-to-the-finish-line/
“French drug developer Genfit (Euronext: $GNFT) is planning to list itself in the United States as its drug elafibranor continues to be evaluated in a late-stage study for the so far untreated fatty liver disease...”
Random notes on RXII:
— They have done 3 reverse splits in the last 5 years and are on track for a fourth one.
— Have overpromised and under delivered multiple times. Once delayed data two years.
— Have had senior clinical lead “retire” before overhyped data (Pamela Pavco, before cosmeceuticals data which was billed as a cash cow).
— They’ve pivoted from dermal scarring treatment to immuno oncology in recent years. I wish them the best but I would be very very careful of the management and be ready for a few more reverse splits.
TSRO (+37%) CFO Declines to Comment on Market M&A Rumors at Goldman Conf. - Bloomberg
https://www.streetinsider.com/dr/news.php?id=13016036
So pre-planned sales. That’s good to know, thanks.
AMRN CEO Thero Sells 607,611 shares at $19.07
$AMRN DJ CEO Thero Sells 607,611 Of Amarin Corp Plc
— The Daytrade™ (@d4ytrad3) November 14, 2018
Nice sale @ $19.07 avg
Indeed jbog. Glad to know the procedure and your recovery both went so smoothly. I wouldn’t be surprised if by the next 50-100 years humanity is able to treat aging as any other disease and make immortality (or a greatly extended lifespan) an option.
[OT]Scientists Just Engineered Human Heart Tissue That Beats Like The Real Thing
https://www.sciencealert.com/scientists-grow-heart-tissue-that-beats-like-the-real-thing
Moderna aims to raise $500 million in biotech’s largest-ever public offering
https://www.statnews.com/2018/11/09/moderna-aims-to-raise-500-million-in-biotechs-largest-ever-public-offering/
Moderna, Inc. Form S-1
When you really, really, really want to ensure universally positive sell-side coverage. $MRNA pic.twitter.com/ttnQ1thPaz
— Adam Feuerstein ✡️ (@adamfeuerstein) November 9, 2018
After seeing results from 8 patients/volunteers, they have decided to sell only 1.2-1.4M shares in this raise and not more. Could this be interpreted as a bullish signal?
I agree. 2 years makes a big difference in the value of the warrants. The typo can deter potential investors.
VYGR -12% after execs say FDA has reversed course on an accelerated filing for its gene therapy
https://endpts.com/voyagers-shares-sink-after-execs-say-fda-has-reversed-course-on-an-accelerated-filing-for-its-gene-therapy/
You are welcome. Just FYI the 2017 10K has a typo for expiration date of NDRAW (says 2020) but it has been confirmed by the company that that is a typo indeed and the actual expiration date is in 2022.
Strike price $6.25
Expiry date May 12, 2022
That’s a valid question. I think pricing up offerings in small chunks as price improves is not a bad strategy for a small company that’s trying to limit giving away equity. Imagine if they had issued all the shares at $2.10 last month vs. only doing a little then and a little now at $3.90. We are better off this way even if there’s that thought of another offering in the near future. Perhaps it will come at a higher price.
Laurie is explaining the potential reason behind current raise at this time by discussing the conditions around the previous raise.
See this thread (thoughts from Suicidal Laurie)
$NDRA Troubling that they didn’t wait for the trial data to be released BEFORE the offering. What do they know?
— Obee1CanoBee (@TKTOM) November 8, 2018
NDRA prices 1.2M shares at $3.90 with 45 day option to purchase another 180K shares
http://investors.endrainc.com/prviewer/release_only/id/3457809
A star drug in Mallinckrodt’s $1.2B Sucampo buyout flops in pivotal trial
https://endpts.com/a-star-drug-in-mallinckrodts-1-2b-sucampo-buyout-flops-in-pivotal-trial/
FWIW, Michael Thornton, NDRA CTO at the CC yesterday:
Absolutely the Pharma’s that we've spoken to, they are absolutely interested in monitoring the fat along with the inflammation markers because an efficacy of a drug should show reversal in both indexes inflammation markers and fat content.
Brooks O’Neil (Lake Street Capital, also covers TNDM)
...So I was hoping you talked quite a bit about, the steps you're taking with the CE mark effort and getting regulatory approval for the European Union. Could you just help us to understand your assessment of the size and the attractiveness of the European market as well as the steps you need to take to get approval in the United States and sort of how you assess the market opportunity in the U.S.?
Francois Michelon (CEO)
Sure. Thanks. I'll speak first to the European market opportunity. The reason we're going to Europe, first is multifold. Number one, if you look at our investor presentation, our addressable market in terms of ultrasound units on the ground in use that we could target and sell to is actually higher than in the U.S. We have about 78,000 estimated ultrasounds in the European Union alone.
Number two, the regulatory path as many of you know, for the CE mark, while rigorous is mostly a safety designation and therefore slightly easier, I would say, than the 510(k) in the U.S., which is an efficacy designation. So that's another benefit. Thirdly, the reason we're going to Europe, there is a larger share of radiologists using ultrasound in Europe than in the U.S. where very often there are highly skilled technicians and scenographers.
Subsequent to the quarter ended, we raised $3.1 million from the sale of 1,477,750 shares of common stock. The sale was completed at $2.10 per share and without the issuance of warrants to the purchasers. Although, we priced our offering on an unforeseen market downturn, we were pleased with the demand for our shares and for the subsequent appreciation in our share price and trading volume.
We were also encouraged that multiple high quality institutional and retail investors participated in the transaction. As the market remains choppy and unpredictable, we are continually evaluating our capital needs in real-time to ensure adequate capital to support our clinical, regulatory and operational activities. And we'll continue to do so as we prepare for EU commercialization.
As has been emphasized before and in summary, we believe the combination of our asset-light operating model and continued effective and efficient use of cash will position ENDRA to commercialize our TAEUS liver product in the European Union as scheduled.
Agreed. The $3.1M (minus UW fees) should still be enough to get them till end of next month at a minimum when data will be available. As long as they can produce meaningful images, the next dilution should not be an issue.
Agreed (eom).
When the chief clinical officer for two years leaves / is replaced a month before supposedly big data for the company, you know it’s a big red flag. Have been out of this stock for months now thankfully but feel bad for investors.
Other red flags:
—Using a “we are seeing great results on Tavo (monotherapy) alone” narrative in recent weeks when their main trial is a combo trial.
—Announcing an ATM funding agreement two days before data(!)
Not sure why they chose to present premature data that is worse than their previous data on predicted nonresponders. Being absent from SITC would have had a smaller hit on SP than presenting this data. The things said about O’Connor have been spot on.
NDRA CEO Francois Michelon on Q3 2018 Results - Earnings Call Transcript
http://www.seekingalpha.com/article/4218446
[OT]Skyscraper Farms Are About to Go Global
https://www.bloomberg.com/news/articles/2018-10-30/skyscraper-farms-are-about-to-go-global
NDRAW +19%
The warrants have been gaining steadily in the last few days. Are they foreshadowing a move up for NDRA?
[OT]A new, eye-wateringly high estimate of the cost of obesity in the US
https://arstechnica.com/science/2018/11/a-new-eye-wateringly-high-estimate-of-the-cost-of-obesity-in-the-us/
A report released this week puts a surprisingly high figure on the societal cost of obesity in the US: $1.72 trillion annually, or 9.3 percent of GDP. By contrast, the current CDC estimates are in the region of $150 billion, less than one tenth as high.
By far the biggest chunk of that $1.72 trillion is the $1.24 trillion chunk attributed to the “indirect” costs of obesity: the “work absences, lost wages, and reduced economic productivity for the individuals suffering from the conditions and their family caregivers,” the report explains. That is, the bulk comes from costs other than healthcare spending. The estimate for healthcare spending—$480.7 billion annually—is somewhat higher than a range of estimates in reviews of the literature, which hover around $150 to $300 billion, but are still on the same scale.
[OT]'Human brain' supercomputer with 1 million processors switched on for first time
https://www.manchester.ac.uk/discover/news/human-brain-supercomputer-with-1million-processors-switched-on-for-first-time/
SpiNNaker is unique because, unlike traditional computers, it doesn’t communicate by sending large amounts of information from point A to B via a standard network. Instead it mimics the massively parallel communication architecture of the brain, sending billions of small amounts of information simultaneously to thousands of different destinations.
Steve Furber, Professor of Computer Engineering, who conceived the initial idea for such a computer, said: “SpiNNaker completely re-thinks the way conventional computers work. We’ve essentially created a machine that works more like a brain than a traditional computer, which is extremely exciting.
“The ultimate objective for the project has always been a million cores in a single computer for real time brain modelling applications, and we have now achieved it, which is fantastic.”
Interesting twitter thread on NDRA
https://twitter.com/thejadedtrader/status/1058789730161123329
Thermo-Acoustic Ultrasound for Detection of RF-Induced Device Lead Heating in MRI.
https://www.ncbi.nlm.nih.gov/pubmed/29053449/
Abstract
Patients who have implanted medical devices with long conductive leads are often restricted from receiving MRI scans due to the danger of RF-induced heating near the lead tips. Phantom studies have shown that this heating varies significantly on a case-by-case basis, indicating that many patients with implanted devices can receive clinically useful MRI scans without harm. However, the difficulty of predicting RF-induced lead tip heating prior to scanning prevents numerous implant recipients from being scanned. Here, we demonstrate that thermo-acoustic ultrasound (TAUS) has the potential to be utilized for a pre-scan procedure assessing the risk of RF-induced lead tip heating in MRI. A system was developed to detect TAUS signals by four different TAUS acquisition methods. We then integrated this system with an MRI scanner and detected a peak in RF power absorption near the tip of a model lead when transmitting from the scanner's body coil. We also developed and experimentally validated simulations to characterize the thermo-acoustic signal generated near lead tips. These results indicate that TAUS is a promising method for assessing RF implant safety, and with further development, a TAUS pre-scan could allow many more patients to have access to MRI scans of significant clinical value.
Sage's postpartum depression treatment wins efficacy vote
—FDA advisors voted 18-0 that Zulresso (brexanolone) was effective for treatment of postpartum depression.
—Kind of as expected, the panel isn't a fan of home infusion.
—An FDA decision is expected by December 19.
—SAGE remains halted from trade.
MRKR— Billionaire Baker Brothers Quietly Back Marker Therapeutics
https://emerginggrowth.com/billionaire-baker-brothers-quietly-back-marker-therapeutics-nasdaq-mrkr/
[OT]Spinal implant helps three paralysed men walk again
https://www.bbc.com/news/health-46043924