TraderNick

starting from ~120k my goal is to hit 1M by 2028 latest. until then I will invest aggressively and take considerable risk. plan is to ~2x my portfolio each year

[TraderNick @RealTradingNick]

@han_seoul_ohno Good one, but taking the colon dysplasia into account as cancer is kind of misleading. The true rate is 1.0%.

[TraderNick @RealTradingNick]

In plain terms: the drug gets approved, and malignancy incidence is followed in the post-marketing setting and ongoing studies. This is exactly how the EMA handles immunomodulators with theoretical malignancy questions. It is a manageable, well-trodden path, not an approval risk.

[TraderNick @RealTradingNick]

How the obefazimod malignancy question will likely be handled under an EMA marketing authorisation for $ABVX (my area of experience lies there):

The scattered single-case malignancies almost certainly do not block approval.

[TraderNick @RealTradingNick]

Potential risk means: plausible enough to track, not proven enough to restrict labelling heavily.

That classification triggers routine pharmacovigilance plus, typically, long-term monitoring through post-authorisation safety studies (PASS) and registries.

[TraderNick @RealTradingNick]

@seedy19tron I am not so certain if the market will re-consider and swiftly recover once the nothing burger malignancies have been clarified but what I do know is that the bidding teams at BP are certainly laughing their asses off that their deal position greatly improved.

[TraderNick @RealTradingNick]

@pawcio2009 @princetongb You think so? You observe various types of cancers in studies, so there’s no reason to believe they’re all related unless there’s clustering, a high sample size. I can’t completely dismiss them as unrelated but I understand believing it if you have full clinical picture of cases.

[TraderNick @RealTradingNick]

@princetongb @pawcio2009 It’s a weak argument and maybe I cope too hard, but this is reassuring in a way that the malignancies were not at all an internal concern. No one took it serious or even tried to hide or sugar-coat it which makes it quite likely that the cases are indeed most likely unrelated.

[TraderNick @RealTradingNick]

@chaotropy Regulators and BP will see this differently. They will need to monitor it, it will be listed as potential effect, but no black box warning or other consequences (my best guess)

[TraderNick @RealTradingNick]

existing malignant cells to progress, which can manifest faster.
• “25mg showed no cancers, so use the low dose” does not hold. A regulator won’t accept low-dose cleanliness as reassurance.They would assume the same risk could arise at 25mg with more patients and longer exposure

[TraderNick @RealTradingNick]

Why the $ABVX obefazimod Ph3 maintenance malignancies are very likely not a drug-related signal (my view on reasons that count/ don’t count):

• Long-term Ph2 data is the strongest evidence. No malignancy concerns across Ph2b open-label extensions,

[TraderNick @RealTradingNick]

• Management seemed unprepared for the concern. Weak on its own, but you don’t walk in unprepared if something had been flagged internally.

What does NOT count:
• “44 weeks is too short for carcinogenesis” is wrong. The feared mechanism is impaired immunosurveillance allowing

[TraderNick @RealTradingNick]

@AppleHelix This will just be monitored as many other weak signals drugs can give…

[TraderNick @RealTradingNick]

@SorareLaGrinta Well the catalyst is there, but my impression is that it wasn’t digested with a clear view yet. People in BP are very likely smart enough to grab this opportunity, so the next catalyst could be much closer than anticipated…

[TraderNick @RealTradingNick]

With some bitterness on $ABVX: know what you own.
Stellar Ph3 data, no real safety signal beyond noisy single-case events and still it’s down.
The thesis worked perfectly, the price just hasn’t followed yet. Stings after waiting this long. Not easy, but I hold until fair value.

[TraderNick @RealTradingNick]

@CloisterRes This was written without any knowledge on the age and other clinical conditions that the safety team (that deemed all cases as unrelated) has access to.⬇️

[TraderNick @RealTradingNick]

I want to elaborate on the following question: Are the observed malignancies in the $ABVX trial statistically alarming once base rates and reporting are considered?
At the trial's mean age (~42), background cancer incidence is very low.

[TraderNick @RealTradingNick]

@CloisterRes I already did this job ;)
It’s slightly elevated but fully explainable by chance still. Will require some attention in the post-approval studies, but nothing worrisome.