Shemzard

[Shemzard @DataJoh]

@RealTradingNick Indeed ...

[Shemzard @DataJoh]

I would like it to be for Abivax. $ABVX

[Shemzard @DataJoh]

@RealTradingNick All are currently there.

[Shemzard @DataJoh]

@RealTradingNick I imagine this can be attributed to a working session on an important topic. If flights to Paris take place afterward, then the Abivax lead becomes stronger, though not certain ...

[Shemzard @DataJoh]

@HansGnt05391203 @Antifunbw @biotech_jack To mobilize the entire fleet, it must involve at least one significant matter. I had hoped the trip was related to Abivax, but we cannot draw that conclusion at this stage and you may be right ... A trip to Paris could change the picture.

[Shemzard @DataJoh]

@torsemide275 If hoping JnJ's flights to Europe might be linked to Abivax is enough to make you call me an idiot, then your reaction says more about you than about me.

[Shemzard @DataJoh]

@aggregategains @biotech_jack Jets dont get an update when flying over the Ocean. Finally, my expectations were wrong since the jets are in Cork now. Sorry.

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@biotech_jack Probably a fourth one - N30QJ - going to Europe too.

[Shemzard @DataJoh]

@ELYUMAG2 Oui

[Mickeychiku @mickeychiku]

$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!

[Shemzard @DataJoh]

@LewisStz @LeVierBeurre @LowKeyDev00 @profpiscou Pour Bourso, il suffit de partir sur une enveloppe dont la valorisation serait alors supérieure à 200% du capital emprunté pour avoir une marge de sécurité. Par exemple, 250k ou plus sur un CTO/PEA/AV pour emprunter 101k et réduire le risque des appels de marge.

[Shemzard @DataJoh]

@gazz13 @MatthiasBaccino @TraderepublicFR Totalement ... J'ai coupé mes positions actions et je pense ne garder que le DCA sur ETF (acc) pour le coup sur TR.

[Shemzard @DataJoh]

@gazz13 @MatthiasBaccino @TraderepublicFR Au bilan, environ 24€ prélevés

[Shemzard @DataJoh]

@gazz13 @MatthiasBaccino @TraderepublicFR Problème réglé a priori. Les prélèvements ont été "annulés" par des virements. Mêmes types de notifications mais avec montants positifs venant annuler les prélèvements de la veille.

[Shemzard @DataJoh]

@gazz13 @MatthiasBaccino @TraderepublicFR Pour le moment, non ... j'attends de voir si la "correction fiscale" apparaît sur le relevé de transactions. C'est quand même étrange car je ne vois pas de quoi il s'agit et sur quelle base ils récupèrent cela. En attendant, je vais récupérer tous mes relevés et les éplucher ...

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@tchantagore @NicoGacx @Le_Patoff Autant le smicard ne paie pas d'IR(abattement et déduction...), autant l'IR est progressif hors utilisation de dispositifs de réduction d'impôts. Revois tes définitions ...

[Shemzard @DataJoh]

@AnotherKoreanX Let's see if they actually head to Paris and whether people make a big deal out of it.

[Shemzard @DataJoh]

@AnotherKoreanX No positional change has been observed for nearly three hours.