RE: It's not in parallel22 Nov 2023 19:15
Has the 2 week study started:
From C6 completion RNS:
The excellent safety profile of AVA6000 should allow more frequent and/or higher dosing compared with the standard doxorubicin regimen which could in turn improve the outcome for patients.
“Therefore, in parallel with the completion of cohort 7, the Company intends to begin a short study to explore more frequent dosing (fortnightly) of AVA6000 as a first line treatment in patients with soft tissue sarcoma. The study is expected to begin in Q4 2023 subject to receipt of approval of a protocol amendment from the US Food & Drug Administration (FDA).”
Now look at this:
Do protocol amendments require FDA approval?
FDA does not issue “permissions” or “approvals” for protocol amendments, your changes are effective immediately upon the receipt of your amendment by the FDA.
The IRB may request documentation of FDA review of amendments and may hold approval until documentation is received from the FDA.
https://ssri.psu.edu/clinicalresearchguidebook/reporting-new-information-fda-and-sponsor#:~:text=FDA%20does%20not%20issue%20%E2%80%9Cpermissions,is%20received%20from%20the%20FDA.
My take, fortnightly dosing is taken place now along side C7 if IRB have not requested documentation.
Avacta don’t need to RNS fortnightly dosing they did that in last RNS.
If the sixth dose cohort at 310 mg/m2, which is equivalent to 2.7 times the standard dose of doxorubicin has shown a significant reduction in tumour volume.
Then what will 385 mg/m2, which is equivalent to approximately 3.5 times the standard dose of doxorubicin be doing to these tumours….
Roll on the next RNS…
GLA
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