Oramed Receives Positive Feedback From End-of-Phase 2 Oral Insulin CMC Meeting With FDA
Oramed Pharmaceuticals Inc. (ORMP)
Last oramed pharmaceuticals inc. earnings: 4/6 04:46 pm
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Source: PR Newswire
NEW YORK, March 19, 2020 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced positive feedback from its initial End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA) to discuss Chemistry Manufacturing and Control (CMC) of its lead oral insulin capsule ORMD-0801. The meeting, held in February, followed the successful completion of Oramed's Phase 2b trial of ORMD-0801 for the treatment of type 2 diabetes (See Press Release dated November 12, 2019), which achieved its primary endpoint, the reduction in HbA1c compared to placebo at week 12. During this meeting the FDA provided feedback on key issues relating to Drug Product manufacture and supported continuing to Phase 3 clinical development. The Company expects an additional meeting with the FDA following deeper analysis of the data from the Phase 2b trial, durin
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ORMP
Earnings
- 11/9/23 - Beat
ORMP
Sec Filings
- 4/18/24 - Form 4
- 4/2/24 - Form 3
- 3/22/24 - Form SC
- ORMP's page on the SEC website