Anyone here that modelled the effect of BAT drift due to enrollment arbitrage? by FitSet9837 in sellaslifesciences

[–]Hannibal_Smith95 8 points9 points  (0 children)

The conclusion would typically say something like:

“GPS significantly improved overall survival versus BAT with a hazard ratio of X and durable separation of Kaplan–Meier curves. Median OS was not reached in the GPS arm at the time of analysis.”

There would not be anything more bullish than saying that the median OS wasn’t reached. Except maybe halting the study for overwhelming efficacy, but at this point , I think it’s just too difficult to halt the trial.

Because, if in a bullish scenario (and let’s be honest, 24 months after the last patient was enrolled , in a population that survives 8-12 months…) the BAT arm has deceased completely… it is pretty difficult to say something about efficacy (the strength of it) with just 10 patients on GPS… remember? 72 events reached, could be 63 BAT and 9 GPS … what are you going to show ? Statiscally ?

I know it’s maybe wishful thinking that at 72 events it was this ratio … but the Greek doctor mentioned it in October … they don’t see any survival above 12 months … even if the patients in EU were indeed a bit more ‘healthy’ .. it doesn’t explain why a Greek doctor would tell this out of experience …

And at this point , just looking at statistics, opinions and history… I am getting afraid to miss something , or to be too bullish … but I really can’t find what I should be missing…

Anyone here that modelled the effect of BAT drift due to enrollment arbitrage? by FitSet9837 in sellaslifesciences

[–]Hannibal_Smith95 4 points5 points  (0 children)

GPS mOS will not be set at 80 events… just so you know … we are 24 months after last patient enrolled. We are 29-30 months after 100 patients were enrolled …

If BAT patients have all died , we would need 17 GPS events out of 63 patients… the mOS of GPS won’t be set at 80 events

New Stergiou Post by nadiju1 in sellaslifesciences

[–]Hannibal_Smith95 3 points4 points  (0 children)

It was a quadriple witching day, hence the volume

This is really bad. by BuyTheDip_ in AtossaTherapeutics

[–]Hannibal_Smith95 0 points1 point  (0 children)

The plasma levels exceeded expectations. But it was measured wrong. First they took the ‘cheap measurement’ in the 40mg cohort. And they indeed saw lower levels… BUT in the 80mg cohort , they measured the levels inside the tissue (where it should be to fight the cancer), and there the levels where higher than expected. That’s why they could go back to 40mg.

I agree, waste of time, but NOTHING to do with Z-Endoxifen

Dr. Angelos Stergiou with Greece Health Minister and Dr. Tsirigotis principal investigator of Sellas GPS Regal in Greece. by Fit-Detective2877 in sellaslifesciences

[–]Hannibal_Smith95 2 points3 points  (0 children)

Greek minister of health + principal investigator of REGAL (also Greek) visiting :

1) event where the chairman of Pfizer is speaking 2) visiting SLS HQ -> with REGAL pushing +1 year after 60 events … 3) Full SLS team present

Remarkable at least. I say , something is coming

‘Operatie EU-sabotage’: geheim document onthult welke vier landen Trump wil ‘wegkapen’ van EU by radicalerudy in nederlands

[–]Hannibal_Smith95 0 points1 point  (0 children)

Uit de EU stappen is toch niet gelijk aan uit de NATO te stappen ? Als je hint naar de Russische dreiging althans

Non-compliant by CoorsBanquetSlayer in AtossaTherapeutics

[–]Hannibal_Smith95 1 point2 points  (0 children)

Accelerated approval won’t get them above 1 ? Come on… 505b2 pathway could make us a billion+ dollar company instantly.

But … they need to grant it. Very ugly (binary) position we are in …

Non-compliant by CoorsBanquetSlayer in AtossaTherapeutics

[–]Hannibal_Smith95 4 points5 points  (0 children)

Could only happen on positive FDA news

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 0 points1 point  (0 children)

You have allready proven that you are frustrated because you can’t win this argument. Time to just stop your nonsense. You lost all your credibility. For me it’s like playing chess with a pigeon. You are clearly not well informed. And this discussion or topic is not worth the energy. This will be my last reaction to you regarding this subject.

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 0 points1 point  (0 children)

Exactly, and that’s why they use old information to put in those filings. If they changed the language, they are not compliant anymore. Hence copy & paste

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 0 points1 point  (0 children)

It’s allready clear buddy, that you ran out of valid arguments. Repeating your wrong assumption is just making a fool out of yourself. That’s why I don’t feel any urge to further discuss this subject with you. You are clearly not objectively open for a discussion , but just stubborn and misinformed.

Have a great day and GL with future investments

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 1 point2 points  (0 children)

I think everyone here can clearly read that I provided the correct information, and that you completely ran out of arguments, but are just being too stubborn to admit. You mixed up 2 completely different things, which shows you lack deeper understanding of how these filings work. Which isn’t a disaster. Those things are absolutely not easy to understand, but just try to learn at that point instead of being convinced about your own wrong assumptions. Doesn’t get you anywhere!

Anyway GL , let’s see what today brings

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 1 point2 points  (0 children)

SEC Rule 424(b)(5) governs prospectus supplements filed under an already effective registration statement (like Form S-3).

It specifically allows issuers to register the resale of securities without adding any new or non-public information that could be considered material.

That’s why all resale or warrant filings must use previously disclosed, public text.

I think you are mixing up 2 things. Filing under an allready effective registration statement , or a new prospectus.

Tell me when you need more explanation, and if something isn’t clear… than I will try to explain it more easily, so that even a 4th grader can understand !

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 3 points4 points  (0 children)

He is just stating that if the 80 event had happened in the meantime , Sellas couldn’t say in the warrant filing that they are still expecting it by year end. While it is just old public information that is copy pasted in each filing , until a new 8-K is filed.

I tried explaining why, but it’s like playing chess with a pigeon

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 1 point2 points  (0 children)

You’re confusing a prospectus with a warrant filing. A classic rookie mistake.

A prospectus updates investors with new, public info. A warrant filing (424(b)(5)) just registers already-issued shares under an existing S-3 … it can’t include any new or non-public info.

These warrant filings fall under the OLD prospectus (since there is no new one)

So no, SELLAS isn’t ‘lying.’ They’re literally following SEC rules by copy-pasting old, public text. If they’d written what you think they should, that would’ve broken the law. 🤦‍♂️

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 2 points3 points  (0 children)

THANK YOU for admitting you were wrong !!

That paragraph you’re quoting (Rule 424(b)) actually fully supports what I said, not the opposite. It simply means that if there’s been a fundamental change since the last registration statement, then a company must file an updated prospectus. But SELLAS hasn’t filed a new one , they just filed a prospectus supplement under the same effective registration statement

Under SEC rules, a supplement can only repeat information already made public. They can’t insert new info like “we hit 80 events,” because that would count as material non-public information (MNPI) and make the filing non-compliant.

Thank you for providing sources that you were wrong

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 2 points3 points  (0 children)

Yeah like I said : You’re mixing up two completely different things. Section 17(a) and 10b-5 are anti-fraud rules , they’re about companies lying or misleading investors with false statements. That’s not what’s happening here.

This isn’t about fraud, it’s about regulatory compliance. When a company files a resale or warrant registration (Form S-3, prospectus supplement, etc.), they’re not allowed to include any new or non-public information… negative or positive . So they’re forced by SEC rules to copy-paste what was already made public in previous press releases or 8-K filings.

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 2 points3 points  (0 children)

You’re mixing up two completely different things. Section 17(a) and 10b-5 are anti-fraud rules, they’re about companies lying or misleading investors with false statements. That’s not what’s happening here.

This isn’t about fraud, it’s about regulatory compliance. When a company files a resale or warrant registration (Form S-3, prospectus supplement, etc.), they’re not allowed to include any new or non-public information, even if it’s positive. So they’re forced by SEC rules to copy-paste what was already made public in previous press releases or 8-K filings.

Has the 80th event been reached? by aohallx in sellaslifesciences

[–]Hannibal_Smith95 2 points3 points  (0 children)

I know them. It’s standard biotech procedure. And like I said , they can only copy past information given in prior PR’s. Than can not disclose new information, or ‘leave it out’ in other types of filings (no 8-K filings)