Sofie

[Sofie @sofie886]

Daprodustat can't sell bc 1) no real advantage over ESAs, 2) label requires 4 months of stable dialysis (switching when nothing's broke is a hard sell), and 3) ESRD bundle (nephs know TDAPA is temporary & anemia is forever). $AKBA's vadadustat faces same issues w/ worse safety

[Sofie @sofie886]

$AKBA CEO @ JPM 2024: "Of the 558,000 patients on dialysis very, very, very few are on daprodustat today. Almost all of them are on an ESA."

But vadadustat will fare better with add'l hepatotoxicity monitoring requirement, seizures warning and drug-drug interactions 🤠

[Sofie @sofie886]

Demand for oral HIF-PH inhibitors is so great among dialysis patients that GSK [checks notes] decided not to even launch daprodustat in Europe after getting approval $AKBA

[Sofie @sofie886]

Getting similar p-value for ADAS-COG (p=0.18) but even using the original mean changes listed on the slide, I get p=0.065 for 2-sided Welch's t test; $AVXL exaggerated the p-value for ADAS-COG by running it 1-sided. Same for CDR-SB. So $AVXL failed no matter what data you use

[Adrian H @Adrian_H]

Check out our poster at #CTAD22 presenting our analysis of the science behind Simufilam, and our attempts to experimentally test the binding of Naloxone and Simufilam to their purported pentapeptide target. $SAVA

https://t.co/BOhP2uH2Yl

[Sofie @sofie886]

$CLNN Can't disclose # of events in placebo other than to say it's <10. No we can't explain how this makes sense when all primary/secondary endpoints whiffed. No we can't explain why the high dose didn't corroborate this or show any HD data. Trust us, we're the good guys🙂

[Sofie @sofie886]

@jesse_brodkin Please show some rispect, Anavex has put a lot of effort into their trial:

[Sofie @sofie886]

@Biohazard3737 IG spread is increasing, HY spread is a straight line up, and QT just started. Nearly all sovereign yields increasing globally at the same time. Bold to assume yields have peaked

[Sofie @sofie886]

@jesse_brodkin Very nice call

[Sofie @sofie886]

Per Cowen, $PMVP enrolled 14 total patients in the >=2000 mg groups and saw one confirmed PR. 15 patients enrolled in the 150-1150 mg groups, also one confirmed PR. 😬

[Sofie @sofie886]

@Sanctuary_Bio $MESO remestemcel-l last August

[Sofie @sofie886]

@MicrobiomDigest Hi Dr. Bik, I would love to listen to your talk but I can only find the Spanish recording. Is there a recording in available in English?

[Sofie @sofie886]

@zbiotech Where is the overall rate of SAEs instead of the rate of each individual SAE? From the Phase 1 trial:

[Sofie @sofie886]

@jq1234t Two of those responses came from the first three patients in the dose finding part of the study where there were no responses in the higher dose groups, and response rates dropped off a cliff after the first 9 patients when they opened up enrollment

[Sofie @sofie886]

@pharmacreep @semodough Excellent call. It takes a lot of courage to short this stock into ASCO-GU given the current environment and their aggressive January press release.

[Sofie @sofie886]

Investor: "Were there safety imbalances in Phase 3?
$BCLI: "We saw similar safety in Phase 3 compared to Phase 2"
Phase 2 safety: