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Posted On: 11/15/2020 9:54:26 AM
Post# of 148908
U.K. BLA or equivalent filing for HIV possible next week? Then the same for Canada’s HIV BLA equivalent filing right after. Since we had the pre-BLA meeting with Canada last Monday.
The U.K. approval timeline is 14 days after filing to accept or not. If accepted then 60 days to render decision to possibly approve or not. If filed early next week. We could be looking at revenue in late January or early February from a HIV BLA.
Do we know the Canadian approval process? Length of time to accept then review and approve?
Maybe the U.K. and Canada jump on board of good CD-12 results and give their PIM approval for Covid before any BLA approvals for HIV.
I think that is the expectation of Nader to see possible revenue earlier than the BLA’s. Nader did say we could have revenue this year. Our BLA filings won’t provide revenue this year. Only a CD-12 EUA and or equivalents in other countries will provide revenues. He is banking on an FDA exemption of the wait for the 42 day post completion of the trial and wants a 14 day post completion review that will have the bulk of the 293 patients past the 42 days. That’s the only way we get revenue this year is with a 14 day exemption for review. We have to be getting close to filling our 75% interim review. Hopefully we get some kind of update next week.
We are so close to something happening. It’s feeling like I am 4 years old and the day before Christmas I am weighing and shaking presents under the tree to find out what might be coming for our presents. The biggest present of all for me this year would be an EUA approval before years end. I would send that list to Santa but forgot the address. I have personally been to North Pole Alaska and know that’s just a small town commercial trap on the main Highway. Santa doesn’t really live in Alaska I guess. If only I could get him my list. We all would have a great Christmas. Even though we can’t go celebrate with our families because of suggested holiday stay at home and stay safe suggestions. Second on my list is celebrating next holiday season with my kids and their families. Oh... how our lives have changed this year. Let’s hope next year returns us back to where we use to be. Also Know as the good Ol' days.
The U.K. approval timeline is 14 days after filing to accept or not. If accepted then 60 days to render decision to possibly approve or not. If filed early next week. We could be looking at revenue in late January or early February from a HIV BLA.
Do we know the Canadian approval process? Length of time to accept then review and approve?
Maybe the U.K. and Canada jump on board of good CD-12 results and give their PIM approval for Covid before any BLA approvals for HIV.
I think that is the expectation of Nader to see possible revenue earlier than the BLA’s. Nader did say we could have revenue this year. Our BLA filings won’t provide revenue this year. Only a CD-12 EUA and or equivalents in other countries will provide revenues. He is banking on an FDA exemption of the wait for the 42 day post completion of the trial and wants a 14 day post completion review that will have the bulk of the 293 patients past the 42 days. That’s the only way we get revenue this year is with a 14 day exemption for review. We have to be getting close to filling our 75% interim review. Hopefully we get some kind of update next week.
We are so close to something happening. It’s feeling like I am 4 years old and the day before Christmas I am weighing and shaking presents under the tree to find out what might be coming for our presents. The biggest present of all for me this year would be an EUA approval before years end. I would send that list to Santa but forgot the address. I have personally been to North Pole Alaska and know that’s just a small town commercial trap on the main Highway. Santa doesn’t really live in Alaska I guess. If only I could get him my list. We all would have a great Christmas. Even though we can’t go celebrate with our families because of suggested holiday stay at home and stay safe suggestions. Second on my list is celebrating next holiday season with my kids and their families. Oh... how our lives have changed this year. Let’s hope next year returns us back to where we use to be. Also Know as the good Ol' days.
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