Whalatane
19 hours ago
An IA of the study primary hypoglycemia endpoint is being conducted following the accumulation of sufficient patient data and is designed to optimize the study sample size and statistical confidence in the final analysis outcomes. . my emphasis
The IA will be conducted at the end of this quarter and the Company plans to announce the conclusions of the DMC early in the second quarter of 2025 while also providing additional overall study updates.
There are three possible outcomes from the analysis: (i) futility and the study should be stopped, (ii) continue the study as is or (iii) continue the study as is but increase the sample size by 33% (18 additional patients) to enhance statistical confidence in the final outcome.
IMHO it's not unusual to optimize a trial after the DMC collects some actual data . It increases confidence in the final result .
Interim analysis conducted by a Data Monitoring Committee (DMC) can provide significant benefits for optimizing the power of a clinical trial. This practice has become increasingly common, especially in large, long-duration, and multi-center studies.
Benefits of DMC Interim Analysis for Trial Power Optimization
Enhanced Statistical Power
Interim analysis allows for the assessment of a trial's statistical power while it is still ongoing. This enables researchers to make informed decisions about potential adjustments to the study design, such as sample size modifications, to ensure adequate power for detecting clinically meaningful effects3.
Adaptive Design Opportunities
DMCs can facilitate adaptive trial designs, where interim analyses are used to guide decisions about continuing, modifying, or stopping a trial. For example, in a recent adaptive design study, the DMC conducted two planned interim data reviews:
At 12 weeks, they assessed the effect on the primary outcome measure.
At 24 weeks, they evaluated whether the trial had adequate power to achieve a statistically significant effect on the primary endpoint3.
Based on these analyses, the DMC could recommend stopping for futility, increasing the trial size, or continuing as planned.
Resource Optimization
By allowing for early stopping due to futility or overwhelming efficacy, interim analyses can help conserve resources and prevent unnecessary continuation of trials that are unlikely to yield meaningful results4.
Ethical Considerations
Interim analyses can enhance the ethical conduct of trials by ensuring that participants are not exposed to ineffective or potentially harmful treatments for longer than necessary1.
Prevalence of DMC Interim Analyses for Power Optimization
The use of DMCs for interim analyses, including power optimization, has become increasingly common in clinical trials:
Regulatory Recommendations: Both the FDA and EMA strongly recommend the use of DMCs for certain types of clinical trials, particularly those that are large, long-term, and involve serious health outcomes7.
Increasing Adoption: The use of DMCs has evolved and increased since their introduction in 1967. They are now used across various therapeutic areas and trial phases5.
Industry Standard: DMCs are considered standard practice for many randomized trials, especially those utilizing important clinical endpoints such as survival or disease progression8.
Expanding Applications: While initially focused on safety monitoring, DMCs are now commonly involved in effectiveness analyses and other interim evaluations that can impact trial power4.
Kiwi
Whalatane
20 hours ago
THx but Laurent on the AMRN board knows far more .
Many dont know this but R-IT could have been stopped at the first Interim
In the REDUCE-IT trial, the first interim analysis showed significant results for both the primary and key secondary endpoints.
For the primary endpoint, which was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or unstable angina requiring hospitalization, the P value at the first interim analysis was 0.000051. This analysis was conducted at approximately 60% of events, with a median follow-up of 2.9 years and 953 first events1.
For the key secondary endpoint, which was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, the P value at the first interim analysis was also 0.000051.
These highly significant P values at the first interim analysis demonstrated the strong efficacy of icosapent ethyl in reducing cardiovascular events among the study population. The consistency of these results across both primary and secondary endpoints, as well as their persistence through subsequent analyses, underscored the robustness of the treatment effect observed in the REDUCE-IT trial1.
They probably hit a P value of .01 ( one chance in 100 that results due to chance ) around 2 yrs into that trial ......
With RZLT .. they appear to have enough cash to run into / thru 2026 ...if they need to add more to the trial.
Having come this far they will want to be absolutely certain the trial is powered properly
JMO
Kiwi
Whalatane
5 days ago
I tend to avoid trading . The P 3 results for RZ358 will be out mid 2025 so I'll hold for those .
Meantime
REDWOOD CITY, Calif., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company dedicated to developing transformative therapies for rare diseases with serious unmet needs, today announced that management will participate in the Guggenheim SMID Cap Biotech Conference, taking place February 5-6, 2025, in New York City.
Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their Guggenheim representative.
I'm sure they'll use this opportunity to try and sell RZ 402
Kiwi
BadCuda
5 days ago
Nice 3 day run , not sure why we haven't heard anything , Still wondering how 3 million shares went thru last Thursday and the price didn't move? no press release or info on the trade makes me worry , Hopefully there's news coming . Looks like someone jumped in early (inside info) before news hits , or it could be MM pump for their future short. should I say current short , which increased again by 140000 plus the 40k from Dec .11.3% increase - what do they know - maybe that why the price is going up on low volume now . I'm flipping it so that's my 2 cents been selling some today between 5.15-5.20, might pop tomorrow morning and I'll sell some more . Don't think Feb 11 quartly report is gonna be any thing at all , what's there to report. I may be wrong but that's my read , if the stock continues to bounce between 5.50-4.25 I will continue - hopefully they partner with another pharma to roll out RZ402 and this sucker takes off . But until then we watch and try to make money flipping . I usually trade some above the 7 dma when the Williams indicator is -20 or better on a 9 month chart (if your a chartist) volume doesn't seem to mater these days , Macd is a tight but in the positive barely . Looks like a bear trap to me but we'll see .
Whalatane
2 weeks ago
I tend to think its a fund like Vivo Capital , starting or expanding their stake in the Co
Vivo Capital's holding represents approximately 33.23% of their portfolio value in Rezolute, with a total value of $13,401,002 as of the reported date7.
Rezolute's total shares outstanding as of June 30, 2024, were 51,465,0002. However, more recent data from January 2025 indicates that the shares outstanding have increased to 57.94 million5.
Vivo Capital is listed among the top institutional shareholders of Rezolute, along with other notable investors such as Federated Hermes, Inc. and Nantahala Capital Management, LLC36.
They or Nantahala may have raised their stake to just under the 10% ownership level that triggers SEC requirements for more frequent reporting
JMO
Kiwi
BadCuda
3 weeks ago
Great video sent out by the company tonight , they've had people on this drug for 2.5 years successfully. Incredible that they know it already works , just gotta finish jumping thru US hoops and we'll see it roll out . Test results be in by this June , if it models the international results , we're good to go . MM's shorting this sucker every chance they get, another 40k on 12/31/24 - on top of the million they shorted at 1.10 , I'll be selling when we short squeeze their asses .Buy back on the dips , watching my charts closely.
Whalatane
4 weeks ago
Also. RZ358 has been granted a priority medicines (PRIME) designation by the European Medicines Agency (EMA) and an Innovation Passport designation by the U.K. Innovative Licensing and Access Pathway (ILAP) Steering Group for the treatment of cHI.
RZ358 also received orphan drug and pediatric rare disease designation in the U.S., and orphan drug designation in the European Union for the treatment of insulinoma, the primary cause of islet cell tumor hypoglycemia (ICTH).
Under the Company’s Expanded Access Program, multiple individuals with ICTH have been successfully treated with RZ358 resulting in substantial hypoglycemia improvement, discontinuation of intravenous dextrose, and hospital discharge.
Ceo in his earlier M&A days worked on the sale of NEXT for Steve Jobs ...before moving into Biotech
Kiwi
rosemountbomber
4 weeks ago
Rezolute (Nasdaq: RZLT), a late-stage biopharmaceutical company, announced that the FDA granted Breakthrough Therapy Designation to ersodetug (RZ358) for treating hypoglycemia due to congenital hyperinsulinism (HI). This designation, aimed at expediting the development of treatments for serious conditions, is based on Phase 2b (RIZE) study results showing significant hypoglycemia improvement of 75% or better without clinically significant hyperglycemia.
CEO Nevan Charles Elam highlighted 2024 as a transformative year with key clinical milestones. The company plans to finish recruitment for the sunRIZE study and announce topline results in the second half of the year. Additionally, Phase 3 study for tumor HI is set to commence.
Key highlights from 2024:
FDA lifted partial clinical holds on the Phase 3 sunRIZE study, enabling U.S. site inclusion.
Received Innovation Passport Designation from the U.K. for congenital HI treatment.
Preclinical validation for treating hypoglycemia due to non-islet cell tumors (NICTs).
FDA clearance for a Phase 3 study for tumor HI, with topline results expected in 2026.
Received Orphan Drug Designation for tumor HI.
Raised $73 million in June to support clinical programs and operational goals into Q2 2026.
Whalatane
2 months ago
CFO open market purchases ...ie these were not RSU, options vesting etc ...he had to put up the cash for these buys ....might have been thru an LLC
12/9 10,549 shares at $5.04 = $53,166
12/12 9,000 shares at $4.60 = $ 41,400
-----------------
$ 94,566
So he is not buying in anticipation of some immediate good news as that could be seen as insider trading . He probably anticipates a good read out from their RZ358 trial with top line results mid 2025 ( that trial is fully enrolled ) . He probably can't make purchases ( or sales ) close to the read out .
Kiwi
Whalatane
2 months ago
This was the CFO's last buy back in May
Tuesday, May 28, 2024 2:55:20 PM
Post# of 429
CFO buying https://ir.stockpr.com/rezolutebio/sec-filings-email/content/0000912282-24-000460/form4.html
These shares were purchased in multiple transactions at prices ranging from $3.21 to $3.23, inclusive
So it's up almost 50% since that purchase ....and 357 % year to date .
All my biotechs were selling off today ...so called " long dated assets " ...vulnerable to any increase in interest rates .
Top line data for RZ358 is not due till mid 2025 and theres be no update on any interest / possible sale of their DME oral drug RZ 402 which they said they would not develop themselves .
May add more comment later but in brief if the CFO is buying I am also ( RZLT ) and if the CFO leaves the Co for other opportunities , I sell what ever I'm still holding ( AMRN ) .
ARDX / UNCY ... Congress seems unable to act in the best interests of dialysis patients . The dialysis bundle as currently administered clearly discriminates against this , mostly people of color , population . Huge frustration for my wife and others that prescribe to these patients , as they are unable to get the best in class drugs for many of them
Kiwi
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Monksdream
2 months ago
