The term "Conditional approvals" are used in the EU! Unless your question pertains to the EU. Please reach out out privately if you need further help or clarification! Good luck with your program!
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GRSAOnline
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Original Message:
Sent: 25-Jul-2023 17:33
From: Bani Tchekanova
Subject: Oncology Conditional approvals
Thanks for your response Narayan however, accelerated approval is different than conditional approval. They are not same thing and the requirements are different as well.
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Bani Tchekanova
Escondido CA
United States
Original Message:
Sent: 25-Jul-2023 17:27
From: Narayan Rao
Subject: Oncology Conditional approvals
Please check my response under the thread "Orphan Drug Designation"
It depends on the targeted population/indication, unmet medical need, choice of endpoint used, how strong the clinical evidence is in this unmet medical need population the phase 2 trial design etc.......In the US, we use the term 'Accelerated' approval not conditional.
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GRSAOnline
Original Message:
Sent: 25-Jul-2023 17:09
From: Bani Tchekanova
Subject: Oncology Conditional approvals
Dear team,
Any thoughts on conditional approvals for Oncology products? I have a product that has ODD, in phase III. I like to know if I can request conditional approvals based on Phase II data while completing phase III.
Appreciate everyone's thought on this?
Sincerely,
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Bani Tchekanova
Escondido CA
United States
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