ENDRA Provides Update Following In-person Meeting with FDA
ENDRA Life Sciences Inc. (NDRA)
US:NASDAQ Investor Relations:
investors.endrainc.com/prviewer/release_only/id/2807436
Company Research
Source: Business Wire
Increases clarity for ENDRA on regulatory path forward for TAEUS ANN ARBOR, Mich.--(BUSINESS WIRE)--ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced that it has completed what it considers to be a highly informative pre-submission meeting with the U.S. Food and Drug Administration (FDA) related to the clinical trial design of the TAEUS liver device in support of its U.S. De Novo filing.Prior to the meeting, ENDRA provided the FDA with a detailed description of the TAEUS technology to be used in clinical testing, along with a clinical study synopsis outlining a prospective hypothesis-driven, statistically powered multicenter clinical study spanning a fat fraction range representative of steatotic liver disease in the U.S., ranging from healthy to severe. In support of the proposed statistical analysis plan, ENDRA provided background clinical data and statistical analyses from 45 historical study participants.The meeting wa
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News
- ENDRA Life Sciences Inc. (NASDAQ: NDRA) had its price target lowered by analysts at Ascendiant Capital Markets from $10.00 to $8.00. They now have a "buy" rating on the stock.MarketBeat
- ENDRA Life Sciences Announces Pricing of $8.0 Million Public Offering [Yahoo! Finance]Yahoo! Finance
- ENDRA Life Sciences Announces Pricing of $8.0 Million Public OfferingBusiness Wire
- ENDRA Provides Update Following In-person Meeting with FDA [Yahoo! Finance]Yahoo! Finance
- ENDRA Life Sciences to Report First Quarter 2024 Financial Results on May 14, 2024Business Wire
NDRA
Analyst Actions
- 6/7/24 - Ascendiant Capital
NDRA
Sec Filings
- 6/14/24 - Form SC
- 6/14/24 - Form SC
- 6/12/24 - Form PRE
- NDRA's page on the SEC website