Exondys 51 and Vyondys 53, both developed by Sarepta Therapeutics (SRPT), are intended to treat a severe form of muscular dystrophy, though in different subgroups of patients. Exondys 51 gained FDA approval in 2016 amid great controversy. Agency officials were divided because evidence of the treatment’s benefits was especially thin. Its approval came with a condition requiring Sarepta to carry out a post-approval clinical trial to confirm the drug’s effectiveness.Like Exondys 51, hundreds of drugs have been given accelerated approval by the FDA since the early 1990s. As long as a drug targets a serious or life-threatening disease for which few, if any, treatments exist, approval is granted on the basis of studies that predict — rather than establish — clinical benefit. Where medical need is acute, access to a new, promising, but unproven drug is considered to outweigh the risk it might otherwise pose.Itsagas: Like others on HC state Sarepta need ATL1102’s to help them be a $6 billion MC Coy..Their only FDA approved drug for 13% DMD boys have another 2 years to show the drug is beneficial.. otherwise they will have a MC lower than Anp..$$ —————/———————————- Sarepta having seen the prelim Anp results will be running a rule over the data ..Anp Board will not accept anything under $2 bid for ANP.. Reasons above———-
ANP Price at posting:
9.4¢ Sentiment: Buy Disclosure: Held
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