Bionerd51
@Bionerd51
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$SRPT Why would the EU ignore this type of data. A very good argument can be made the the Duchenne historical data External Control is more accurate a placebo cohort than what was used for the 1st 48 weeks
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$SRPT 2 YR dataset Elevidys Vs. EC. Part 1, Year 2 (n=63) ELEVIDYS-Treated vs. EC Functional Outcomes LSM P-Value NSAA +2.88 points P=0.0001 TTR -2.06 seconds (improvement) P=0.0033 10MWR -1.36 seconds (improvement) P=0.0028
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$SRPT Grok 3 Yes, Roche intends to appeal the European Medicines Agencyβs (EMA) Committee for Medicinal Products for Human Use (CHMP) decision not to recommend conditional marketing authorization for Elevidys (delandistrogene moxeparvovec) for the treatment of ambulatory indi
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$SRPT Does anyone know if Roche has filed an appeal on the EU Elevidys decision?
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$SRPT Duchenne patients, present and future, all should thank former Pennsylvania senator Rick Santorum for the firing of CBER Director. He directly spoke with HHS Kennedy and Trump close allies.
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$SRPT Anyone want to wager that CBER Vinay Prasad was Adam F.'s "high FDA official" used in his biased reporting on Sarepta ?
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$SRPT Should be trading much higher after yesterday's announcement. Large milestone over hang with potential of one large dilutive event. Still hopeful that BOD shows CEO the exit. His reputation will hold this company back.
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$SRPT Godfather...Just when you get out they pull you back in.....
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Ingram's managing of $SRPT 's budget is downright misfeasance. Share buyback, line of credit, 1.4 billion payment, Arrowhead deal, 1500 employees, 3 deaths that were "immaterial" etc. This was a slow motion train wreck. BOD is complicit.
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$SRPT Feurestein: your reporting is different from Bloombergs. Bloomberg reported that the FDA standard is no more deaths. Adam F. report that SRPT must prove that Elevidys is "safe". Quite different!
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$SRPT Per Bloomberg, "Elevidys must not cause more deaths". That's an easy one. Ambulatory Duchenne patients treated with Elevidys has not caused one death. Quick resolution for this cohort.
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$SRPT If the FDA intends on going thru the process of removing Elevidys because of the capsid does that mean they will also remove Zolgensma for SMA? Similar Gene therapy capsid with multiple deaths.
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$XRP Finally reached $3.30 π As promised, I want to change someone's holiday and send 10,000 $XRP (~$33,000) to one person by tomorrow. Just like, retweet and comment '$XRP'. Random winner in 24 hours. I will announce as a tweet at 12pm EST Sat
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$SRPT It looks like Ingram keeps his job. No longer President so I guess he lost one of his jobs. What is a "Chief People Officer"?
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$SRPT Where's the PR regarding restructuring and reduction in workforce? Why did we have 1500 employees? If we are lucky Ingram will be one of the 25% of the employees no longer employed
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$SRPT Is there a way to knock out all of these spam posts without blocking each poster individually? Thanks. This board is unreadable.
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$SRPT The so-called FDA investigation is routine. There are over 20 drugs currently under investigation by the FDA Likelihood is that none of them will be remove from market. Non story.
domain-b.com
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$SRPT Good CEO's rise to the occasion when the company he is managing hits troubled waters. Bad CEO's HIDE! This is what we have now.
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