Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
Oramed Pharmaceuticals (NASDAQ:ORMP) is awaiting a decision from the FDA, possibly later this week, to conduct a sub-study of the safety of its oral insulin candidate, ORMD-0801, before proceeding to a large, multi-center Phase 2 clinical trial later this year.
"Approving a clinical trial in the U.S. for oral insulin is a big deal," CEO Nadav Kidron says in an interview with BioTuesdays.com. "We are ready to start the sub-study right away."
On April 12, Oramed submitted a new IND application for the sub-study, which suggests that a decision could be made by the end of this week. The filing was in response to an initial IND for a Phase 2 trial that Oramed had filed at the end of December. For the sub-study, Oramed plans to enroll 30 Type 2 diabetic patients in a controlled in-patient setting for up to one week, with data likely available in four-to-five months.
http://seekingalpha.com/article/1411471-oramed-readies-oral-insulin-study-in-u-s
"Approving a clinical trial in the U.S. for oral insulin is a big deal," CEO Nadav Kidron says in an interview with BioTuesdays.com. "We are ready to start the sub-study right away."
On April 12, Oramed submitted a new IND application for the sub-study, which suggests that a decision could be made by the end of this week. The filing was in response to an initial IND for a Phase 2 trial that Oramed had filed at the end of December. For the sub-study, Oramed plans to enroll 30 Type 2 diabetic patients in a controlled in-patient setting for up to one week, with data likely available in four-to-five months.
http://seekingalpha.com/article/1411471-oramed-readies-oral-insulin-study-in-u-s