Oramed Reports Positive End of Phase 2 Meeting With the FDA for Oral Insulin
Oramed Pharmaceuticals Inc. (ORMP)
Last oramed pharmaceuticals inc. earnings: 4/6 04:46 pm
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Source: PR Newswire
NEW YORK, July 15, 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 that the FDA provided positive feedback during the company's End of Phase 2 (EOP2) meeting for Oramed's oral insulin (ORMD-0801). Based on the FDA's feedback, Oramed intends to initiate two Phase 3 clinical trials following FDA review of those Phase 3 protocols, and nonclinical documents. The FDA outlined its expectations for design of the ORMD-0801 Phase 3 trials as well as submission of the Biologics License Application (BLA) that would follow successful trials. Oramed plans to conduct the two Phase 3 trials concurrently. Oramed's Chief Executive Nadav Kidron said, "We are very pleased with the results of our meeting with the FDA and look forward to submitting our finalized protocols for the Phase 3 trials to the FDA. Following successful Phase 3 trials, we
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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