Let’s put this in perspective, for her to pass these kind of training, they had to lower the bar just enough for her to pass! And seeing what we saw in the past few years, the leadership in that unit, isn’t the most mission focused oriented, they are more concerned with the judicial system staying in tact rather raising the bar!
@VerminusM They receive 0%, 0% of Jerusalem, and right of return for 0.
They intend to take by force whatever we dont give them (literally Arafat's Plan of Phases), so dont give them any greater ability to fight, dont give anything for free. Let them try and fail at all of it.
@GravityAnalyti1 If there is no financial reward from preventing disease, why are vaccines profitable?
And why did Gilead spend $11 billion to buy Pharmasset?
And on and on...
***The Cancer Signal DOES NOT Exist $abvx ***
BREAKING:
Building on what Adam has said, I’ve been able to crack it, and I think in the coming days when mgmt release a PR this is going back to $160. Here is why: (try to read to the end)
When you apply the standard clinical trial counting conventions that every other UC pivotal trial has , you exclude dysplastic lesions (which are by definition not cancer) and separate NMSC from serious malignancies (per FDA convention). So it isn’t what Adam and I are observing it’s a fact. The actual count of adjudicable malignancy cases in the Ph 3 50 mg arm is TWO:
- one prostate cancer
- one breast cancer
Why nothing burger?
- Both occurred in older patients at peak demographic incidence ages
- both were investigator deemed unrelated
- both occurred at exposure windows biologically incompatible with drug causation
- Obe has neither of the two known mechanisms by which a drug can cause cancer.
*The signal is statistical noise made to look like a signal by a self inflicted presentation error.*
Okay so clearly $abvx shot themselves in the foot, a $7B presentation error:
The cleanest single fact in this entire debate…colonic dysplasia is not cancer.
Cervical dysplasia, colonic dysplasia, melanocytic dysplasia… none of these are cancer.
Every other UC pivotal program excludes dysplasia from the malignancy count. Look at the Rinvoq maint safety table, Sotyktu’s , Omvoh Velsipity, all the same.
Dysplastic lesions are tracked separately as GI surveillance findings!!! not as malignancies.
$abvx in a rush or naively included colonic dysplasia in the malignancy row created a non apples to apples comp that the market has been processing as drug driven cancer when it from a clinical pov, not cancer at all.
This was a self inflicted wound. But it will be correct very soon. What they should have done.. (in hindsight gave us a chance to buy so so cheap)
1.Footnoted the dysplasia as a UC surveillance finding, NOT a malignancy
2.Reported “drug related malignancies 0%” prominently
3.Provided case level details for every event with explicit rationale for the unrelatedness adjudication
4.Released the escape/placebo arm 50 mg data simultaneously
They visually organized the data in a way that made a non signal look like a signal. The market reacted to the table layout not the underlying pharmacology!!
NMSC is not in the same category and if anyone wants I can walk them through it.
Lumping NMSC with serious malignancies is a categorical error that no oncology or dermatology specialist would make. (Adam a derm and multiple others I spoke to confirm this)
It is in a meaningfully different clinical category and the FDA knows this… which is why “non NMSC malignancy” is the standard endpoint they evaluate.
Lots of smart onco folk here … there are exactly two established pharmacological pathways by which a drug can cause cancer:
- Direct DNA damage (genotoxicity / mutagenicity)
- Profound immunosuppression
Obe non genotoxic across the full ICH S2 panel and no clin immunosuppression signal.
CLEARED!
if Obe is causing cancer, it must be doing so through a mechanism that has never been described in pharmacology. The drug would have to either be acting as a mini Chernobyl in a small subset of patients… (sorry for this example)
There is no third option.
The shortest known cancer latency for any human malignancy is approximately 2 years for radiation induced acute leukemia from acute high dose exposure. That is the floor.
Chernobyl level acute radiation exposure does not cause clinically detectable solid tumors in 40 days. It doesn’t cause them in 200 days or 400 days. The biology requires multi year cellular transformation processes. Cancers detected within a 44w trial were growing for years before the pt was randomized.
1/n
@AmichaiChikli He was a follower and errand boy of the Blind Sheik and testified as a defense witness at his trial.
The guy is literally an al qaeda terrorist. And NJ might elect him!
@Duke0035 "The circularity is treating price action as proof that the market’s safety read is correct."
I never once said that. You (or your AI) misunderstood my tweets.
@Duke0035 Look i'm getting sick of these canned AI responses.
What was "walked back?" I'm trying to explain to u that youre convinced this update will totally assuage everyone's concerns and renew all optimism about it obe, but it might not do that.
Do u even acknowledge that possibility?