This draft guidance is wonderful in that FDA reminds us that there has been a long-standing precedent (decades) for use of external controls as "substantial evidence of effectiveness" and approval.
But is it relevant?...
fda.gov/media/164960/d…
$NWBO #Murcidencel Glioblastoma
But is it relevant?...
fda.gov/media/164960/d…
$NWBO #Murcidencel Glioblastoma
This draft guidance is focused on "patient-level data" which might not relate to #Murcidencel - In that case, FDA would be able to cite the decades old precedent.
Recall that Avastin and Optune were both FDA approved but didn't improve survival in rGBM, unmet need.
$NWBO
Recall that Avastin and Optune were both FDA approved but didn't improve survival in rGBM, unmet need.
$NWBO
In summary, this draft guidance is overall positive for $NWBO as it
1 shows FDA flexibility and precedent for use of external controls as substantial evidence of effectiveness
2 aims to formalize a portion of the precedent into official "guidance" for industry
$XBI Cancer Vaccine
1 shows FDA flexibility and precedent for use of external controls as substantial evidence of effectiveness
2 aims to formalize a portion of the precedent into official "guidance" for industry
$XBI Cancer Vaccine
See Smith on Stocks below for a similar but different POV - He suggests the new draft guidance is very positive for use of historical controls, particularly in orphan diseases like GBM.
$NWBO
smithonstocks.com/northwest-biot…
$NWBO
smithonstocks.com/northwest-biot…
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