
BaffledBiologist
@BlaseBio
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Why do people put "not investment advice" in their bios? Is there actually legal precedent, or do they just do copy others? Not investment advice.
Joined December 2023
Well said. Wonder how much the agency will stand by their 'patient first' approach in light of all these incoming $REPL letters.
Letter to the FDA Commissioner from Dr Mo Milhem, the investigator who enrolled the greatest number of patients in Replimune's IGNYTE clinical trial, re $REPL and RP1
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Nice to see $BFRI finally getting some attention following the royalty amendment and massive margin change. Growth every quarter, finally a path to profitability, precedent M&A, no new innovations in AK treatment. excited to see where this goes.
$BFRI royalty rate has gone from 25-35% (going up after this year) down to 12%. $11M financing, which company says will bring to cash flow break-even. Competitive drug (Dusa/Sun Pharma) was acquired and had high scripts post-acquisition. Both have long IP- could split the mkt.
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I deeply believe that in the long-term, science outweighs all. Couple other products on the market that should be pulled, but none as overt as this one (that I know of). Not going to comment on *the* company who recently got screwed by the FDA- but, science will outweigh all.
Exclusive: $SRPT would have to conduct new studies to get back on market, FDA official says - CBER review staff are 'unanimous' that Elevidys should never return to market
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$SRPT seems like they have FDA teflon. - $400M annual cost savings, 36% RIF (500 employees).- $513M in 2Q25 revenues.- Black box warning for ELEVIDYS.- additional prophylactic immunosuppression for non-ambulant patients.
investorrelations.sarepta.com
โ After strategic review, Sarepta focuses pipeline on high-impact programs, prioritizing potentially best-in-class siRNA platform assets โ Strategic restructuring includes reduced operating expenses,...
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