http://www.managingmds.com/index.php?op ... 6dd2ba4ae9
Likelihood of approval is extremely high. Note discussion of disease modification. Dr. Steensma does not emphasize the more stringent entry criterion for Imetelstat study(c/w Lus) which is perplexing. He does acknowledge the high placebo effect in the Lus study which I think weakens the Lus study. His discussion is very low key and reservedly professional. bp
Worth watching this timely video
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Re: Worth watching this timely video
Thanks biopearl for another great find. Interesting site and video was quite informative, definitely worth watching! I was impressed with Dr. Mikkael A. Sekeres, who also seemed very interested in Imetelstat, maybe more so than Dr. David P. Steensma. Also, like you, I was surprised that DS didn’t put emphasis on the TB difference between Luspatercept and Imetelstat trials. DS also said the Imetelstat MDS trial was a Phase 1/2 trial, likely a slip but important mistake in my mind for anyone watching not familiar. Found it interesting that DS is doing something of a balancing act between Luspatercept and Imetelstat. Giving Luspatercept the frontline at least until confirmatory results are provided from the Imetelstat Phase 3 and can document a sustained level of differentiation.
MS covered many different trials and treatments for MDS as well as educating us further on the IPSS used to discern the MDS level diagnosis and the importance of mutations. It was interesting to see how busy the MDS trial landscape is and what’s being tried including some combinations. Really liked the back and forth between Drs. MS and DS. I think it accentuates the importance of expediting the IMERGE study in whatever way possible.
Thanks again.
MS covered many different trials and treatments for MDS as well as educating us further on the IPSS used to discern the MDS level diagnosis and the importance of mutations. It was interesting to see how busy the MDS trial landscape is and what’s being tried including some combinations. Really liked the back and forth between Drs. MS and DS. I think it accentuates the importance of expediting the IMERGE study in whatever way possible.
Thanks again.
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Re: Worth watching this timely video
Thanks Hunt, it actually wasn't my find. Hat tip to Richard on YMB for this one (and many others). bp
Re: Worth watching this timely video
Interesting to see the clinician's perspective... and how they miss important aspects of their field.
So frustrating to hear him say he would prescribe Luspatercept instead of imetelstat "because of cytopenias"... GERN and Janssen have known about the cyptopenia issue for years, and there are simple, obvious countermeasures for it. (NAD+ boosters probably being the safest, but there are plenty of patent-medicine solutions as well).
Doctors live in a completely different world, inside the FDA bubble, where it's always around the year 1975... while outside, polo ponies and police dogs are cloned, gene therapy works, and there's simply no excuse for giving up on any effective drug for "cytopenia" side effects.
https://www.scienceandtechnologyresearc ... ood-cells/
https://www.cnn.com/2019/03/21/asia/chi ... index.html
So frustrating to hear him say he would prescribe Luspatercept instead of imetelstat "because of cytopenias"... GERN and Janssen have known about the cyptopenia issue for years, and there are simple, obvious countermeasures for it. (NAD+ boosters probably being the safest, but there are plenty of patent-medicine solutions as well).
Doctors live in a completely different world, inside the FDA bubble, where it's always around the year 1975... while outside, polo ponies and police dogs are cloned, gene therapy works, and there's simply no excuse for giving up on any effective drug for "cytopenia" side effects.
https://www.scienceandtechnologyresearc ... ood-cells/
https://www.cnn.com/2019/03/21/asia/chi ... index.html