Shares of SRPT are sinking again, after weeks of gains, following an FDA decision to permit extended use of drugs in trials, for compassionate purposes. In other words, they’re scared to deny SRPT’s muscular dystrophy drug, so they’re simply going to create an awkward middleground, whereby the company can only recover its manufacturing costs for the drug, a situation that isn’t economically feasible.
Sandy Walsh, spokeswoman for the FDA, rebuffed the notion that their decision had anything to do with SRPT, saying ‘this decision had been in the works for a long time.’
Right. Sure.
Even if that were true, to leave important drugs like this in limbo, making it available to patients in trials but not for profit for the companies, is unfair and bodes poorly for drug development of rare diseases.
Why drop the coin on developing a drug if the FDA is simply gonna toss it into purgatory?
SRPT is getting hammered on the news.
Not sure what the problem with the decision is here. It seemes like their are three choices:
1) Approve
2) Deny
3) Extend
These seem to go well with the three possilbe evaluation outcomes:
1) Good
2) Bad
3) Inconclusive
In other words, if there isn’t enough evidence to either approve or deny SRPT’s new drug, then I think the FDA acted appropriately. Once more results come in, they can then approve or deny as the evidence warrants