$Citius Pharmaceuticals (CTXR.US)$ Continue As Planned DMC S...
$Citius Pharmaceuticals (CTXR.US)$ Continue As Planned DMC Says. So Why The Negativity(my notes ONB) Now from the PR!
Citius Pharmaceuticals, Inc. Announces Positive Recommendation by Independent Data Monitoring Committee to Continue the Mino-Lok® Phase 3 Trial as Planned
- DMC interim safety and efficacy review of Mino-Lok® Phase 3 Trial concluded with favorable recommendation to continue the trial as planned, with the protocol-defined sample size and power to achieve the primary endpoint –
- Citius to proceed in conducting largest controlled clinical trial to salvage infected catheters with no modifications requested by the DMC and no safety concerns identified -
CRANFORD, N.J., July 1, 2021 -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today announced that following a unblinded data review of safety and efficacy, the independent Data Monitoring Committee (DMC) for the Mino-Lok® Phase 3 Pivotal Superiority Trial has recommended proceeding with the trial as planned. The DMC did not identify any safety concerns and no modifications were recommended to the protocol-defined sample size or power to achieve the primary endpoint.
“We greatly appreciate the thoughtful analysis and guidance provided by the Data Monitoring Committee following their review of the interim trial data. Consistent with our expectations, we are pleased with the DMC recommendation to continue this trial without modification. This marks the third recommendation by the DMC supporting the continuation of the Mino-Lok® trial. With each DMC review, the hurdles to meet our protocol-defined criteria for safety and superior efficacy increase. Consequently, this favorable outcome indicates that based on our pre-defined parameters, it would be possible to achieve our primary endpoint by continuing the trial as planned, and is an encouraging signal when combined with the results of our prior studies,” stated Myron Holubiak, President and Chief Executive Officer of Citius.)
Disclaimer: Community is offered by Moomoo Technologies Inc. and is for educational purposes only.
Read more
Comment
Sign in to post a comment
Retired VP MfgTech Start-Up.Swing,DT, Scalp.Learner, Helper.
30KFollowers
458Following
28KVisitors
Follow
Damon Li : The expectation this time is to wrap up the Phase III clinical trial and move on to the next FDA application![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")
70581462 : Why the price dropped today?
OldNormanBates OP 70581462 : Because of the expectation that this would be the end date for approval, not more time. But was not that negative of letter. Back to CTXR just go as planned, everything so far good. It'll come back quickly.
JunJun Jai : Any idea when phase 3 will be end?
OldNormanBates OP JunJun Jai : looks like delayed for at least until end of year. But waiting until more PR comes out on it. They need to put out something in Filing now to give investors more idea. I'm just guessing.
OldNormanBates OP JunJun Jai : wrong with last notice, I decided to delete:
So my second thought is this is not the direct FDA Trial situation, it's the DMC which is the Data Monitoring Committee which is the groups of Dr and Scientists, separate from FDA, who help in defining efficacy of trials in Double Blind Situations.. It Is part of the holistic approach: see attached
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4118004/
70581462 OldNormanBates OP : thank you!
JunJun Jai OldNormanBates OP : Thanks for the info :)
AndyConda Damon Li : Omg no Patients people.
OldNormanBates OP AndyConda : Everyone needs to stay calm and be able to wait for the good things in life, instead of trying to make life a pump and dump..
View more comments...