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Review the transcript from the 3/25. After I reviewed it I would say the answer to your question is NO.
Do they need data from the recent university partnership studies in order to obtain FDA approval?
I am FDA approval anyday, more drug partnerships, more patents, and sales. Double digits are coming.
Looking at the chart you could be right if we get one of those tails like we have seen twice before.
I think $2.10 is rock bottom
I want to get some more on the low 2s too
Call me greedy but I'm hoping for a pullback near 2 bucks
Huge endorsement & derisking event for NDRA & their TAEUS technology.
Hepion Pharma commits to using TAEUS in their critical Phase 2b NASH study even though TAEUS has not received FDA 510k Clearance yet??? Unprecedented IMO. This is strong evidence of just large the market for TAEUS will be...
Consider the opinion of someone who is not long NDRA but has done his due diligence. In fact, he is the CEO of another company. And he is bullish on TAEUS:
"Hepion Pharma is excited to incorporate ENDRA's technology into screening for our Phase 2b study of CRV431, which targets non-alcoholic steatohepatitis (NASH) and other liver diseases," said Hepion's CEO Dr. Robert Foster."
"... there is enormous potential value in capturing data on the degree of hepatic steatosis and other biomarkers to refine our understanding of systemic variables associated with NAFLD-NASH. We believe ENDRA's TAEUS system is uniquely designed to accomplish this task for us."
http://investors.endrainc.com/prviewer/release_only/id/4662746
ENDRA Life Sciences to Report Fourth Quarter 2020 Financial Results on March 25, 2021
https://finance.yahoo.com/news/endra-life-sciences-report-fourth-200500452.html
Nice collaboration announcement... LFG!!!!
https://finance.yahoo.com/news/endra-life-sciences-hepion-pharmaceuticals-120000579.html
Funny they hadn’t even submitted there application to the FDA one year ago!
Funny, we said the same thing one year ago
Technically there were insiders purchasing because at least half reached into their own pockets to cover taxes on shares versus selling shares to cover those same taxes.
The average time for this type of devices is 8 months. I'm expecting it by the end of this month hopefully if there's no delay due to covid.
Gotcha. Well fingers crossed these research partners are impressed with the accuracy. Also I keep checking insider trading and only automatic sells in the last 3 months which is good. No purchases though.
You have all the information that is out there at this point.
I've been bullish on Endra for a couple years now, but as we await further news about FDA and in light of the recent Colorado and European university collaborations, do you guys recall seeing any independent data showing TAEUS efficacy compared to the current standard of care (MRI)? Is there any possibility that these universities come back and say, "Nope, sorry your product is not sufficient at determining liver fat in an acceptable manner"? I do recall seeing something that they had data based on their protoype and ENDRA saying that the commercialized product would be even better and more accurate than their prototype.
Any day the sky turns blue.
https://www.accesswire.com/630080/ENDRA-Life-Sciences-Announces-New-Clinical-Study-Partnership-with-Inselspital-University-Hospital-in-Bern-Switzerland I know it is a couple of weeks old but still good news!
Got me 12k shares maybe 13k for luck. Stalking this biatch for a month 321 like my number lol
What’s that you say up sharply?
Bet you would rather be in NDRA today then our other stock.
Yep I bought more just like you with your fav.
Down sharply!!!
Looking forward for the 10k. Sometimes in mid march?
Interesting...A shell company. Not that there is anything wrong with that. Paper..
No not even close. We won't see earnings report until March most likely.
The Key issue right now is FDA decision.
CriTech Research designed the TAEUS software for NDRA.
From the CriTech website: " Our work has a 100% first-time acceptance rate from FDA."
CriTech was founded in 1994, specializes in medical software development, has completed over 450 projects and has 100% submissions approved by both FDA & EU over 27 years of experience.
NDRA submitted its FDA 510k application late June 2020. Likely approval is due anyday now.
Check out the CriTech website:
https://www.critech.com/compliance/
The design & manufacturing of the TAEUS platform is outsourced to Starfish Medical & CriTech Research. NDRA does not plan to bring the manufacturing in-house. NDRA is partnered with GE Healthcare who is helping with marketing & introducing TAEUS to their GE customer base. This is all consistent with NDRA's light asset model business strategy & will greatly reduce manufacturing & commercialization costs.
Yes excellent. You know something's afoot when the first 100 Warrant Buy of mine went off at .489899 this AM....
$NDRA
Pumped about this, was making me nervous prior to the run-up.
Endra now in compliance at the NASDAQ.
https://listingcenter.nasdaq.com/noncompliantcompanylist.aspx
I've thought for some time that ENDRA is a monster. Awaiting FDA approval, followed by sales of TAEUS. ENDRA could achieve a hefty market share in liver diagnostics globally.
$NDRA/W
HUGE for NDRA's TAEUS diagnostic platform:
Rebecca Winderman, MD, Director of the Dept of Pediatric Gastroenterology, Hepatology & Nutrition at Jamaica Hospital Medical Center in Richmond Hill, N.Y. :
"Well this is a bombshell. Huge meta-analysis evaluating some 4,000 patients showed 25% of patients with Non-Alcoholic Fatty Liver Disease (NAFLD) had normal ALT. Numbers weren’t any better for patients who had advanced to Non-Alcoholic Steatohepatitis (NASH) 19% of whom also had normal ALT value."
"We DESPERATELY need non-invasive bio markers for NAFLD and NASH. For now, liver biopsy remains gold standard."
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage... it is unreliable with NAFLD & NASH...
Bottom line, the medical community is desperate for the TAEUS technology which is approved for CE Mark in Europe & pending FDA 510k approval.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6961232/
Yeah definitely not normal
anticipation of the 510k plus flippers to join in for a quick buck. I said few days ago the off hour trades look not normal to me, it seems like a trap.
But what explains the run up on no news? Rumors?
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