$ABVX. I agree that the trial time frame was likely too short to conclude Obe caused cancer, but perhaps not the dysplasias. And the problem is they are predictive of future cancer. So what I'd like to see is a comparison of Rinvoq dysplasia rates to Obe. We need a compelling, conclusive comparison vs other treatment options to convince investors that Obe is the best risk/reward option, or at least identify the patient subpopulation where it is and define the revenue opportunity as such.
From a search: Colonic dysplasia is identified because it is the definitive, direct cellular precursor to colorectal cancer. It means the epithelial cells lining the colon have acquired genetic mutations that alter their size, shape, and organization, veering away from healthy tissue and moving toward malignancy. Gastroenterologists and pathologists call out dysplasia to intercept the "adenoma-to-carcinoma" sequence, removing these abnormal growths before they breach the tissue barriers and become invasive cancer. The primary risks of a colonic dysplasia finding involve its progression to malignancy and the subsequent medical or surgical burden required to manage it. The most severe morbidity is the development of invasive, life-threatening colorectal cancer. While dysplasia is non-invasive (it has not broken through the tissue's basement membrane), it provides the exact foundation cancer needs to form. The speed and likelihood of this progression depend directly on the grade of dysplasia:Low-Grade Dysplasia (LGD): Cells are mildly abnormal. In patients with chronic conditions like Inflammatory Bowel Disease (IBD), studies from Clinical Gastroenterology and Hepatology show that patients with LGD are 3.5 times more likely to develop advanced neoplasia or cancer over a 15-year period than those with no dysplasia. High-Grade Dysplasia (HGD): Cells look severely abnormal and mimic cancer architecturally. Longitudinal data indicates that up to 40% of patients with high-grade dysplasia go on to develop colorectal cancer if left unchecked. 2. Synchronous and Metachronous Malignancies: A finding of dysplasia indicates that the environment of the colon (often due to aging, genetics, or chronic inflammation) is actively prone to cellular mutation. This introduces two specific structural risks: Synchronous Cancer: The hidden presence of a separate, fully developed cancer elsewhere in the colon at the exact same time the dysplasia is found. Metachronous Cancer: The development of entirely new, separate dysplastic lesions or cancers in different regions of the colon later in life. 3. Increased Treatment and Surgical Morbidity: Identifying dysplasia alters a patient's medical trajectory, swapping standard prevention for aggressive clinical management. This shifts future care toward several invasive outcomes: Proctocolectomy / Bowel Resection: If dysplasia is widespread, recurring, or "invisible" (flat and scattered across the colon lining), a patient may require a surgical colectomy to remove part or all of the large intestine to eliminate the cancer risk. This comes with major lifestyle impacts and potential surgical complications. Aggressive Endoscopic Resections: Large or complex dysplastic polyps require advanced endoscopic mucosal resections, which carry inherent, immediate risks of bowel perforation or severe internal bleeding. Stringent Surveillance Burden: Once dysplasia is detected, a patient is locked into a high-frequency colonoscopy pipeline. Instead of a screening every 10 years, follow-ups drop to every 3 to 6 months initially, and then annually, increasing the cumulative lifetime risks associated with repeated sedation and bowel preparations.
For Rinvoq: incidence rate of dysplasia across all Phase 3 trials remained exceptionally low, typically falling between 0% and 0.8% depending on the specific organ system and patient cohort. Because Rinvoq carries an FDA Boxed Warning regarding the potential risk of malignancies (cancers), dysplasias are heavily monitored as potential pre-cancerous precursors. To review the overarching safety data, malignancy event rates (excluding non-melanoma skin cancers) across the long-term Phase 3 IBD trials were documented at an Exposure-Adjusted Event Rate (EAER) of 0.6 events per 100 patient-years for the 15 mg dose, and 1.0 event per 100 patient-years for the 30 mg dose.
Even with all the bearishness and expected declines in Rs, Linear, FCF, etc, it looks like $VSNT could have the firepower to buy back the entire company out of FCF within the next 5-6 years. (FCF this yr alone could be $2b, and the mkt cap is about $6.4B)
@StocHoliday84@jonnajarian Love the way he followed his brother out of the back, chose not to go what appeared to be the shorter but potentially contested "tweener" route (maybe respecting his brother), then still was able to win it from the outside.
$UNF Getting an exact entry point is a little trickier than opining that a deal should happen, but my 2 cents would be 1) there is some doubt of approvability, 2) the process to approval is about 6 months +/- a couple months, 3) about 1/2 the value in $CTAS stock, so there is still stock market risk. So when I consider it all, I think the odds of getting more than $300 per share in value within 6 months are pretty good, but I'd want 15% or so to tie up the capital, so my buy range would be around $260 +/- $5. But of course the factors are constantly changing, so that number would constantly change.
Looks like $UNF shareholders are finally getting somewhere. The silence and lack of activity in the stock has been encouraging up to this point, but still has tested patience!
In 2022, $UNF could attempt a few weak arguments to substantiate their opposition to a sale. Now they can't. The enormous underperformance vs. the S&P and $CTAS is too great for anyone to defend for $UNF, so no one can make the argument to go it alone with a straight face IMO. And even if $CTAS can't get the deal across the goal line, what's wrong with the $UNF getting 10% of its market cap in cash for the exercise. Hard to argue that $275 is not a win, and they might be able to get more. If they don't take it, there seems to be a very good chance IMO of them presiding over a market share losing, declining value situation for many years to come. There would be nothing rational about declining this offer IMO, and employees would likely be better taken care of with a combination of generous severance and a much more competitive future than the bleak, share losing future that appears to be in store if $UNF goes it alone.
@FlowbyBobby well @FlowbyBobby@JK15181325 $UNF maybe next time you will report it more accurately as "whale buying 210 calls" instead of "whale selling"
$UNF has ignored or declined prior very attractive offers from $CTAS to the detriment of all common shareholders per the decisions of the supervoting Croatti family IMO. There is no reason for this company to be public when the non-supervoting shareholders are blatantly discriminated against IMO. Given the past history of disregard for non-family shareholders, and the obvious error of the board’s decision-making in retrospect IMO (as demonstrated by years of lagging performance), the Board’s decision to engage or not in a process to maximize shareholder value and consider offers should be a material, disclosure-worthy decision by the board IMO. Having known of takeover interest for at least a month, if not longer in my estimation, and given prior experience with such, why it has yet to be disclosed that a process is either ongoing or not is beyond me. Long ignored shareholders are at least entitled to know whether they will be mistreated again or not, and withholding this material information makes analysis for shareholders impossible IMO. Therefore the board should be required to disclose the very material fact of whether a process has been undertaken to maximize shareholder value or not. Isn’t it a violation of securities laws to withhold such information, and hasn’t enough time passed to decide?
@EscapeVlcty yes, it's been very quiet for a long time. The other side of the coin is that there will be huge disappointment if after all this time, nothing happens, but it seems logical to me that the longer we go, there should be only one answer to the question, why is this taking so long.
$UNF has ignored or declined prior very attractive offers from $CTAS to the detriment of all common shareholders per the decisions of the supervoting Croatti family IMO. There is no reason for this company to be public when the non-supervoting shareholders are blatantly discriminated against IMO. Given the past history of disregard for non-family shareholders, and the obvious error of the board’s decision-making in retrospect IMO (as demonstrated by years of lagging performance), the Board’s decision to engage or not in a process to maximize shareholder value and consider offers should be a material, disclosure-worthy decision by the board IMO. Having known of takeover interest for at least a month, if not longer in my estimation, and given prior experience with such, why it has yet to be disclosed that a process is either ongoing or not is beyond me. Long ignored shareholders are at least entitled to know whether they will be mistreated again or not, and withholding this material information makes analysis for shareholders impossible IMO. Therefore the board should be required to disclose the very material fact of whether a process has been undertaken to maximize shareholder value or not. Isn’t it a violation of securities laws to withhold such information, and hasn’t enough time passed to decide?