WC
@Sanctuary_Bio
Biotech investor. Tweets reflect my own opinion
This goes back few weeks back where FDA committed to "radical transparency" by releasing CRLs for a bunch of drugs that were eventually approved Let's see the RP1 CRL, & proof 3rd death for srpt was "lost to bureaucracy" But we won't because then we'd know they are full of shit
When a CRL is sent without AdCom but with leadership overriding reviewers' recommendation, the public deserves more transparency. The disclosure of previous CRLs needs to be a forcing function on *both* sponsor and regulator.
well I genuinely hope everyone has a relaxing weekend You know historically in biotech last couple weeks are slowest annually...2025 has been the exact opposite Do whatever makes you happy, whatever you are long or short...take care!
How are FDA decisions on $REPL affecting investors? @EricSchmidt151 says, “Anything that was agreed on in the past needs to be re-agreed upon under the new administration and FDA leadership. There’s going to be a risk of surprises going forward. We all know that investors hate…
$BBIO $ALNY $PFE just lead this call: slingshotinsights.com/projects/4795 K. Alexander is one of my fav KOLs in the space...still so young but incredibly sharp, has a bright future in the attr-cm space, like how he thinks about things. also touch on stuff in pipeline i.e. azn, ions, ntla
This could literally pass as a scene straight from The Office
The best bull thesis for $SRPT honestly is that each journalist article makes them seem more and more blatantly incompetent and after an excessive amount of ridicule they will drop this nonsense to avoid further public humiliation
Does the FDA know what they are talking about or are they just spitballing? This is AE profile of EMBARK. How do you prove enhanced safety profile with n=12 patient trial? Are they retarded?
Ludp halt
Updated: In a follow-up conversation on the safety study, the senior official said Sarepta could make a change to the dosing or manufacturing, and test it on the next 10 or 12 boys, and show the liver-related issues were improved
anyways between SRPT and REPL closed losses of 2.1% my total biotech holdings...which doesn't seem a lot but is absurd considering it was over span of a week, luckily ABVX more than made up for it From the bottom of my heart though, fuck the FDA. What a complete joke.
game over.
Exclusive: $SRPT would have to conduct new studies to get back on market, FDA official says - CBER review staff are 'unanimous' that Elevidys should never return to market endpoints.news/sarepta-would-…