@grok@BobKnoblaw@realstewpeters@grok If the house version had it, then he voted "NO" on it, dummy. While he might of voted yes on those things in other packages, he also voted No on them in context of the OBBB. Trump said he voted No on them - not that he never voted Yes.
@tttheripe@LibertyMatter77@USATODAY Read the last 3 sentences on that page again. They weren't "indicted for paying sources". They were indicted for using fake corporations to create bank accounts and launder money.
@PatrickHenry_II@JustAFamilyMan_@amuse@grok Eh, he didn't have a problem when Biden usurped the role of congress to forgive studen loans, so it's a not a principled stance.
@zerohedge Or re-phrased: Biden-Appointed Minnesota Judge Limits protestors to peaceful demonstrations that don't interfere with Federal Immigration Enforcement Actions.
"Cardiac imaging endpoints were not the primary basis of the original BLA". Ummm, the label was for cardiomyopathy - what do you imagine was the primary basis for the BLA? Also, a lot smart people said no way Prasad approves with such a small n and against natural history when a phase 3 was waiting to be unblinded - they were proven right. You seem to be betting that Prasad simply didn't want to see the same cardiac results with a larger n - good luck with that.
PUL 2.0 wasn't a criterion for the BLA though, at least according to Linda. It's seeking a label for cardiomyopathy. It may be an issue when they ask to expand the label to skeletal muscle. Then again, I guess it all hinges on if Prasad can admit when he's wrong and how much pressure the advocacy groups bring.
@jamesc_867 I guess you know by now, but that's not what the data shows. Whatever AI you used hallencinated that assertion - the underlying studies (Earl 2022, Tandon 2015, Silva 2017) didn't support your LVEF plateau.
@GoldAmman@augurbio@markland_55 Even ALLSTAR showed heart benefit with LDESV decrease of 9.8ml vs 2.3 increase in placebo, same anti-remodeling signal as HOPE-2. https://t.co/pjMhMHfhCp
@drpatrick@VPrasadMDMPH@DrMakaryFDA Talk is cheap. How'd that work out for Capricor? Why LVEF not allowed as primary endpoint? Idiots at FDA would rather use rough PUL scores than cardiac MRIs and making kids wait, cutting down on lifespan and condemning many to wheelchairs earlier than necessary.
@FidelisAurelius@augurbio The placebo group did not get worse at all - in grip strength. In total PUL scores, they declined in line with natural history.