1/ I'm all in short on $REPL
They got rejected because the filed study was not adequate and well-controlled.
Their answer was not to produce a new study.
Their answer was to run the same one back.
CRL is coming๐งต
1/ I'M SHORT $CING
this company is seeking approval for a drug they can't even manufacture.
i paid 300 bucks to see the 483 so you don't have to.
and the details are ugly.
CRL is coming๐งต
@SSampson60391 PDUFA VII says FDA only extends if late info could fix deficiencies this cycle and lead to approval. CING said May 14 it was still advancing validation-batch prep. with this 483, thatโs not close enough IMO. FDA wonโt approve a kid stimulant without consistent manufacture.
13/ my trade is June $2.50 puts at $0.30.
if $CING trades to $1.30 after the CRL, intrinsic is $1.20.
that is 4x gross, or about +300%
see you at cash value.
follow @BiotechAutist
12/ that target is not just me being dramatic.
CING has no product revenue. the lead filing would be failed. the 483 points to manufacturing controls for the actual tablet. the fix requires time, data, and capital. none of which this shitco has rn.