⚡BioYOLO420⚡(Semi Version) @BioYOLO420 - Twitter Profile

@AskRobinhood On Monday evening, the market got a generational buying opp (a dirk) on $ABVX. But Robinhood users could not participate. Correct this injustice ASAP.

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⚡BioYOLO420⚡(Semi Version)

@BioYOLO420

6 days ago

@RobinhoodApp I can trade basketball predictions but not $ABVX ? Get your head in the game.

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⚡BioYOLO420⚡(Semi Version)

@BioYOLO420

6 days ago

Whatever it is, it can wait. First let the people buy $ABVX , preferably starting tomorrow. @RobinhoodApp @AskRobinhood @RobinhoodComms

Robinhood

@RobinhoodApp

6 days ago

T-minus one day. A decades-old trading barrier is going away. 👀

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BioYOLO420 retweeted

Mickeychiku

@mickeychiku

7 days ago

$ABVX Received some questions on how FDA will see this? My views below, some of which some of you have already articulated: FDA doesn’t issue Black Box label like they are issuing bagels. Lot of thinking and negotiations goes into it. BB decisions are based on totality of evidence. Non-clinical, clinical, safety, CMC all reviewers have to come to an agreement that what they are seeing is absolutely triggered by the drug and nothing else. If they conclude it’s the drug, then next step is whether efficacy outweighs potential safety risk? Is this something that can be ignored for now and be asked to monitor in post market safety assessment and reevaluate labeling in 3-5 years if BB is needed at that point? If no conclusion can be reached, Advisory Committee is the last option. If I use Abivax current situations as an example, following will play the role: 1) If high 50mg dose for 52 weeks caused breast and prostate cancer, why didn’t even higher dose and longer duration of total 100mg for 16 weeks + 2 year 50mg + 3 years of 25mg cause those cancers in phase 2 OLM? No drug changes have been made between the trials hence Phase 2 safety data are representative of potential commercial safety as well. Longer the safety data the better. FDA likes it. - Individual patient history: High refractory patients compared to other arms and overall entire study in more severe and prior ~5-6 drug exposure patients. Also use of concomitants and steroids in the trial as standard practice. Is this just carry over from previous drugs? prostate cancer was flagged early during induction and breast cancer appropriate for age. Too early for cancer to trigger. - Robust animal tox studies, pharmacology data, external literatures with no sign of toxicity - No CMC impurities in ~25+ batches of 50mg dose manufactured so far and assessed for any impurity above allowed limit and well characterized new impurities with supportive tox evaluation Based on what we know today, this is heavily tilted toward no BB in my opinion. There should also be pre-NDA meeting with FDA in next 3-4 months. *Not a financial advice. Opinion only!

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