The Feb 26th DSMB PR.....re-examined.
posted on
May 13, 2018 11:53PM
Here's the link:
https://www.resverlogix.com/investors/news.html?article=595
Here's what it says, all bolding and emphasis is mine:
CALGARY, Alberta, Feb. 26, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 BETonMACE trial in high-risk cardiovascular disease (CVD) patients has completed a sixth safety review and recommended that the study should continue as planned without any modifications. The DSMB reviewed available study data and noted that no safety or efficacy concerns were identified, and will conduct additional periodic reviews. Resverlogix, the clinical steering committee, and all investigators remain blinded to the trial data.
"The BETonMACE phase 3 trial now has over 2,300 patients enrolled, representing over 95 percent of the approximately 2,400 patients outlined in the study protocol. We are currently considering the extent to which we enroll beyond 2,400 patients to ensure BETonMACE yields 250 MACE events optimally and to include US patients. We now have patients that have been on treatment with apabetalone for nearly 120 weeks, which is nearly five times longer than any treatment duration in any of the Company’s previous Phase 2 trials. Full enrollment continues to be anticipated in the first half of 2018," stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development.
After that its standard boiler plate, 'about resverlogix...yadda yadda yadda.
This "news" is now coming up on being 3 months old....and in light of recent events I think it worthwhile to put it under the microscope as it were.
That last bolded line....that the company was considering the "extent" to which they would enroll beyond 2,400 patients. Reading that back at the end of February, it seemed to me that an increase in the number of patients was more than just likely...it sounded like a near certainty.
Since then however the company's CEO has given an Investor Presentation, on May 2nd so over 2 months after this Feb 26th PR, saying that BETonMACE is "properly powered", and that they only need 2,400 patients for the trial.
Taken at face value that would mean the extent to which they decided to enroll beyond 2,400 was determined to be zero, nada, zilch. Thanks to the Arabs we have the number 0, if we'd stuck to the Roman system of numbering 0 would not be an option.
Obviously this is significant in my eyes because everything flows from the current trial design...the time lines to top line data and final results, and the all important question of money and how much is needed to get us to those milestones. Increase the number of patients/events and we can push top-line data further down the field and obviously final results as well....and very possibly too far for us to reach them with current financial resources.
So now we should be coming up on the SSRA or at minimum a 7th DSMB reccomendation.
I'm not meaning to "poke the bear", sorry BDZ I can't resisit a cheesy pun. I'm not trying to be combative here, merely trying to understand. The company is blinded to the trial results, but back at the end of February they were considering the possibility of increasing the patient size....the obvious question for me is this: What were they basing their considerations on? And what exactly is the "available study data" upon which the DSMB bases its reccomendations on?
Its been over 2 months since they were "currently" considering enrolling additional patients....and since that time the CEO has publicly stated that 2,400 is the right number and that the trial is "properly powered" at that number.
This is the reason why I'm viewing a SSRA/DSMB report as being pretty much the same for me...with the SSRA simply being "more official". This is a big concern for me because I'm looking to put another check in the box....that indeed the trial is NOT going to increase in patient size, which for me means the likelihood of DM being bang on with his projection of Top Line results by late 2018 , that he's on the money.
Sorry for rambling....had a golf game scheduled for tomorrow but my playing partner cancelled and this is on my mind. Would love to read Bear's, or anyone else's thoughts.