BioQuixote @bio_quixote
sniffin around; unaffiliated Joined June 2022-
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$AGIO Pyrukynd PDUFA for thalassemia extended by 3 months to Dec. 7. Liver toxicity issue. "Following a recent information request from the FDA, Agios submitted a proposed Risk Evaluation and Mitigation Strategy (REMS) to mitigate the risk of hepatocellular injury that was…
$VRTX acquiring $FULC would be hilarious from a terminology standpoint
AHEG scheduled. Sept 2nd $PFE
AHEG scheduled. Sept 2nd $PFE https://t.co/pYXOu69ZUs
Only one way to save the copper price now.
Only one way to save the copper price now. https://t.co/2BfbqLD3UE
$FULC as attention shifts to whether 20mg will achieve 20% HbF: 20% HbF isn't broadly anti-sickling unless its distribution is pancellular. FULC is not. Remember, the curative 30% HbF bar comes from HPFH in which patients are truly pancellular.
$FULC as attention shifts to whether 20mg will achieve 20% HbF: 20% HbF isn't broadly anti-sickling unless its distribution is pancellular. FULC is not. Remember, the curative 30% HbF bar comes from HPFH in which patients are truly pancellular.
$FULC wishing all those patients had HU on board at baseline right about now
Does this mean there's an incrementally higher chance OXBRYTA is reintroduced to the market? For consideration re: $FULC, therefore (incrementally) lower chance pociredir gets to broaden its addressable population? All else equal, this is a +ve devt in the case "For" OXBRYTA!
Does this mean there's an incrementally higher chance OXBRYTA is reintroduced to the market? For consideration re: $FULC, therefore (incrementally) lower chance pociredir gets to broaden its addressable population? All else equal, this is a +ve devt in the case "For" OXBRYTA!
clinicaltrials.gov (quietly) not ASH (loudly). Results posted a couple wks ago. W24 TAMMV: -7.73cm/sec (vox -12.15 vs. -4.42 pbo, p=0.0043) It worked! $PFE $NVO $AGIO $FULC Baseline characteristics from ASH 2023: postersessiononline.eu/173580348_eu/c…
clinicaltrials.gov (quietly) not ASH (loudly). Results posted a couple wks ago. W24 TAMMV: -7.73cm/sec (vox -12.15 vs. -4.42 pbo, p=0.0043) It worked! $PFE $NVO $AGIO $FULC Baseline characteristics from ASH 2023: postersessiononline.eu/173580348_eu/c…
Anyone know the HIBISCUS-1 powering statement? Pls DM
Anyone know the HIBISCUS-1 powering statement? Pls DM
Reason I care: if HIBISCUS-1 was AWC + had >90% pwr on VOCs, why would FDA ask for 2nd Ph3? If '-1 had adequate pwr on VOCs, does this indicate FDA requires 2 (!) AWC post-OXBRYTA? ... $AGIO FDA: "mind doing another Ph3 for us?" Fatigue 2EP won't cut it, probably.
Reason I care: if HIBISCUS-1 was AWC + had >90% pwr on VOCs, why would FDA ask for 2nd Ph3? If '-1 had adequate pwr on VOCs, does this indicate FDA requires 2 (!) AWC post-OXBRYTA? ... $AGIO FDA: "mind doing another Ph3 for us?" Fatigue 2EP won't cut it, probably.
$NVO etavopivat Ph3 HIBISCUS-2 1EP changed 5/30. Post-OXBRYTA snafu (Sep'24), NVO added (Feb'25) 2nd Ph3. 1EP prev composite now just VOCs. Could argue comp has more pwr, but 6MWT is atypical in SCD, and who knows how PROMIS will come in. My view is net dev't win (cleaner study)
@A_May_MD @Sanctuary_Bio @adamfeuerstein @gcbioinv GBT was one of those with smart bulls AND bears. Drug never demonstrated any benefit on any clinical outcome. Basically not useful. BUT it was also novel, innovative, big market,no competition, good enough for FDA = so ideal big pharma take out They were both right in the end.
20% HbF <> 20% HbF <> 20% HbF! Even if $FULC miraculously hits 20% HbF despite mean 7.6% @ BL, pancellularity matters even more. 15pg #HbF is the protective threshold at venous O2 sats. FYI HbF LLOQ with FACS is 6pg ("now it's an F-cell!"). 60% F-cells @ 6pg <> 60% F-cells @ 15pg
20% HbF <> 20% HbF <> 20% HbF! Even if $FULC miraculously hits 20% HbF despite mean 7.6% @ BL, pancellularity matters even more. 15pg #HbF is the protective threshold at venous O2 sats. FYI HbF LLOQ with FACS is 6pg ("now it's an F-cell!"). 60% F-cells @ 6pg <> 60% F-cells @ 15pg https://t.co/EFQhAqDxMi
Scratch that, probably doesn't matter. Vox also showed reticulocyte increases in NHP and went on to show significant reductions in reticulocytes in SCD patients. As always, the data in humans will matter most.
Scratch that, probably doesn't matter. Vox also showed reticulocyte increases in NHP and went on to show significant reductions in reticulocytes in SCD patients. As always, the data in humans will matter most. https://t.co/pVFZfGlhCg
$VRTX 👀
Where is the F-cell data $FULC ? Why the focus on F-retics and not all F-cells (inclusive of erythrocytes)?
(3x charm) Rough napkin in an envelope math. Assuming the median patient takes ~3-4mo from the moment a patient starts stabilizing transfusions to receive #CASGEVY, do $VRTX 's goal posts imply are patients dropping out after collection?
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