Hallelujah! Please, would someone else confirm th
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Posted On: 08/25/2024 9:54:11 PM
Hallelujah! Please, would someone else confirm this?
If an off patent drug (bevacizumab/Avastin) that has already been approved for an indication (MSS mCRC) is combined with an unapproved drug (leronlimab) in a Phase II trial (the proposed MSS mCRC clinical trial priority #1) that is identical to the original trial that won the approval of the off patent drug (bevacizumab), and at the end of that combination Phase II trial (CytoDyn's priority #1), its results were successful and met the clinical significance to causing the FDA to give the go ahead for a Phase III trial (in the future commencing say a year from now 9/2025) using the same combination of off patent and unapproved drugs. Then, after the completion of the Phase III trial, clinical significance was again achieved and after the BLA was submitted, the FDA approved the drug combination for that indication.
The question is, can the original off patent drug (bevacizumab) re-apply for patent in this combination treatment with leronlimab for this MSS mCRC indication and will that new patent again protect that newly patented drug Avastin + leronlimab for another 12 years?
Also, if you can supply any examples.
Thank you so much.
If an off patent drug (bevacizumab/Avastin) that has already been approved for an indication (MSS mCRC) is combined with an unapproved drug (leronlimab) in a Phase II trial (the proposed MSS mCRC clinical trial priority #1) that is identical to the original trial that won the approval of the off patent drug (bevacizumab), and at the end of that combination Phase II trial (CytoDyn's priority #1), its results were successful and met the clinical significance to causing the FDA to give the go ahead for a Phase III trial (in the future commencing say a year from now 9/2025) using the same combination of off patent and unapproved drugs. Then, after the completion of the Phase III trial, clinical significance was again achieved and after the BLA was submitted, the FDA approved the drug combination for that indication.
The question is, can the original off patent drug (bevacizumab) re-apply for patent in this combination treatment with leronlimab for this MSS mCRC indication and will that new patent again protect that newly patented drug Avastin + leronlimab for another 12 years?
Also, if you can supply any examples.
Thank you so much.
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