Biotech Autist

Regulatory Arbitrage. I short certainty.

[Biotech Autist @BiotechAutist]

$REPL
Quiet now.

[Biotech Autist @BiotechAutist]

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 coming🧵

[Biotech Autist @BiotechAutist]

@LoopSnoopa so true king

[Biotech Autist @BiotechAutist]

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 coming🧵

[Biotech Autist @BiotechAutist]

@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, that’s not close enough IMO. FDA won’t approve a kid stimulant without consistent manufacture.

[Biotech Autist @BiotechAutist]

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

[Biotech Autist @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.

[Biotech Autist @BiotechAutist]

@T697029T No. FDA will demand a randomized controlled trial.

[Biotech Autist @BiotechAutist]

1/ I'm long $RGNX

I shorted it at $16. Now I'm long at $8🧵

[Biotech Autist @BiotechAutist]

@blindad3 i am still leaning yes but am less sure about the timing. i bought may 15 puts so i am worried about it too haha

[Biotech Autist @BiotechAutist]

@DavidCh34622985 PUL can be meaningful and still not answer a cardiomyopathy CRL. I could be wrong, that's why I appreciate discussions like these.

[Biotech Autist @BiotechAutist]

1/ FDA vs $CAPR
at their words 🧵

[Biotech Autist @BiotechAutist]

@blindad3 I don't think it will be approved.