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Friday, 02/28/2020 2:01:13 AM

Friday, February 28, 2020 2:01:13 AM

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Good news on the Phase 2b second cohort Topline data. 8mg x1 and x2 dosages resulted in a big drop in HbA1c of up to 1.29%. That would be enough to get diabetic patient with up to 7.29% HbA1c baseline out of the diabetic state entirely. Remember HbA1c of 6-6.4% = pre-diabetic, and 6.5% or above = diabetic.

These results are reported to be statistically significant with p-value = 0.028. Also no important adverse events.

One thing which I find interesting though is that they state that the 1x and 2x dosage of 16mg (32mg) did not reach statistically significant drops, while in the larger 1st cohort, the 1x 32mg did reach statistically significant reduction. Looking forward to seeing the full data set when ready.

Unfortunately though, the news on the 21 million dollar offering. Not sure exactly how much they have at the moment, but should be somewhere between 40-50 million after the offering. Don't think that will get them to Phase III finish-line.

Would have expected a milestone payment from HTIT to have been triggered after finalising Phase II data. Perhaps will come in after successful Phase III meeting with FDA and/or Phase III study start?

While we do need to see the full study data, in general this looks positive for ORMB-0801.

Did anyone get to listen in on the webcast? I was travelling at the time and was about 2am my time.
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