FDA TRADER

With the market being red, fda approvals are at a minimum this month, and a couple CRL’s between December and January.. I have made the premium group $1/month for now. Just wanted to take care of our members! ❤️ $AQST $VNDA $SPY $SPX $XBI $CALT $FBIO $ATRA $PHAR $ETON $SWTX

@Vieczny Did you see the approval

@Biotechmaster12 What do you think about $RYTM? ✅️ or ⛔️?

$ALDX and there it is. Interested to see what the $4 puts open at.

It’s almost time ⏰

We have been shopping this week 🩸 ⚡️ $xbi $spy $rckt $repl $tvtx $dnli $grce

@BiotechAutist Ps: I do have a counter, but don’t feel like posting. I was slightly curious as to what your thoughts were. GL👍🏻

Appreciate the effort, but this is a deeply unserious read of the file. 1/ A Type C meeting is not approval. It means FDA was willing to review the package on that theory. RGNX already showed that can still blow up at action. 2/ “Different from RGNX” does not solve the core problem. DNLI still filed an open-label, nonrandomized, no-control-arm phase 1/2 with safety as the primary objective. 3/ The Takeda trial absolutely matters. It is the only randomized controlled trial in neuronopathic MPS II we have results of, and it gave FDA a concrete reason to doubt that lowering CSF substrate reliably translates into cognitive benefit. 4/ BBB penetration is mechanism, not evidence. A better mechanistic story is not the same thing as substantial evidence. 5/ The clinical signals are supportive. They are not a substitute for control. 6/ Process chatter is not evidence. No AdCom, labeling, PDUFA extension, launch prep, Royalty, Jefferies, none of that answers approvability. 7/ COMPASS being enrolled helps confirmatory posture. It does not make the filed package is enough. Regardless, this is still an uncontrolled biomarker package, and the approval case is basically “maybe FDA stretches.” That can happen. But dressing that up as some obvious base-case approval call is just cope. Ps: Stop having grok write your messages, it's embarrassing.

1/ I’m SHORT $DNLI. They filed a safety study as their pivotal trial in the BLA. This application relies entirely on the clinical assumption that the FDA employs morons who treat uncontrolled substrate shifts like stone tablets from God.

@BiotechAutist Believe what you will brother.

@Investorclimber @plainyogurt21 Grabbed on a dip at 3.64 third time buying was today at 4.35 ⚡️ let’s keep running

@Biotechmaster12 @plainyogurt21 Started a position in $GRCE two days ago at 4.5$ 👍

Fun month in FDA land $ALDX - CRL $RCKT - approved $DNLI - Approved $GRCE - Approved $REPL - CRL

@Investorclimber @plainyogurt21 $GRCE will spike decently on approval

@plainyogurt21 I am short $ALDX and long $RCKT, I also think $GRCE will be approved but not expecting a significant rise in the price, so not playing it yet...considering it though!

@Vieczny Institutional insider selling though so be aware.

@Vieczny 70-75% chance

@mariomastrom Those are odds that scream CRL, and there it is. Under $2

@Biotechmaster12 The poa is 65% … odds have that as favorable for approval

Took profits on $ALDX today. Expecting a CRL

@mariomastrom Doesn’t mean I don’t hope for approval, but the odds are not in their favor. I don’t need luck. I sold already.

@Biotechmaster12 Ok good luck Debby Downer

Almost time to start shopping again $xbi

We've already taken 26% profit on at least 1 ticker for our April plays. If you aren't taking advantage of the $1/month subscription, you're missing out. It will go back to $20 in a month. $XBI $ETON $VNDA $TVTX $REPL $ALDX $RCKT $CAPR

I’m not giving out free plays again until I move the subscription cost back to $20. It’s currently only $1/month and if you can’t pay that then you should re evaluate

This is why we kept shopping every red day:) already over 25% profit on an April play ⚡️

Stilllll shopping ❤️

More shopping going on today