@Southoz
The point you’re attempting to make is pure speculation on your part (like everything else on this forum).
Obviously you’re not privy to what discussions MSB has had and continues to have with the FDA since 2020…that guides their actions.
Do you suppose that MSB hasn’t sought to get clear advise from the FDA as to what steps they need to taking for the BLA submission.
Do you suppose that the FDA didn’t make clear to MSB exactly what they want from MSB?
Do you suppose that the FDA said to MSB this time around…hey you need to do a new double blinded placebo controlled RCT…but MSB decided to go against this advise, increase the risk of them not receiving an approval in the future, and simply go for an “easier” option that suits them…and hope that the FDA won’t mind and grant them an approval?
Feel free to surprise me with a response.
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@Southoz The point you’re attempting to make is pure speculation...
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