Fortunately, Nasrat was prepared for the possibility of having some big legal fights coming down the pike related to SequestOx. That is why he hired Eugene, who has loads of experience and success in handling these battles. ELTP will prevail! SequestOx will be approved and will make a big splash in the market! You will see.
Sorry but Sequests rejection is not a legal issue, it's a safety issue that cannot be remedied with labeling
A legal battle is not too promising. What other drugs have been FDA approved having substantially the same alleged attributes as Sequest (IR ADF OPIOID) including enhanced labeling of sprinkles, applesauce etc ?
Rejection without even an ADCOM is what i dont understand about the whole situation Much worse product have been given ADCOM ADCOM meeting must be anounced on month before PDUFA date So imo FDA knew long before 07/14 sequestOX was a no go Why wait so long? Buying time? Fishy