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Posted On: 12/06/2021 2:23:10 PM
Post# of 154062
Re: onestepahead #111749
That wasn't my impression at all. He used the same words he's used in the past that the FDA reminded them that IF they do get BTD for mTNBC, they will have to file for Expanded Access within 15 days.
NP mentioned that they have a new order from Philippines for $300,000. I can't find it in my notes from previous talks, but I thought that number was mentioned in the past. So I'm wondering if this is another order of that size or just the original one. Does anyone have clarity on that?
The big news was right at the end. NP said that Recknor told him that after going through the data from the 30 patients in the 350 mg open label part of the NASH trial, they hit the primary endpoint and with statistical significance. They're all very excited to see the data from the double blinded 700 mg part of the trial, hopefully this month. If it's as good, they'll file for BTD in NASH.
NP mentioned that they have a new order from Philippines for $300,000. I can't find it in my notes from previous talks, but I thought that number was mentioned in the past. So I'm wondering if this is another order of that size or just the original one. Does anyone have clarity on that?
The big news was right at the end. NP said that Recknor told him that after going through the data from the 30 patients in the 350 mg open label part of the NASH trial, they hit the primary endpoint and with statistical significance. They're all very excited to see the data from the double blinded 700 mg part of the trial, hopefully this month. If it's as good, they'll file for BTD in NASH.
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