Posted On: 02/09/2016 1:24:20 PM
Post# of 72443
Re: Loose Lips #18451
getting their ducks in a row. Do they need to be so public about it? Certainly not. The change of comparison from dapto to vancomycin is a pretty big shift. Getting all the protocols and a full trial design submitted asap. We need to see that they're ready to go.
When brilacidin came up against more competition last month with the label change on dalbavancin I think that put the wheels in motion. Pretty confident that the majority believe we have already beaten daptomyacin.
Here is an excellent key to keep in mind...
... Dr. Trust has more than four decades of pharmaceutical research and development experience, including senior positions in R&D at Pfizer, Enzon, Wyeth/Lederle, and most recently, Allergan plc affiliate Durata Therapeutics. He has made significant contributions leading to the FDA approval of 11 drugs and supplements, including five antibacterial agents, most notably the blockbuster ZITHROMAX® (azithromycin) and most recently DALVANCE® (dalbavancin) for ABSSSI. An organic chemist by training, Dr. Trust received his PhD in chemistry from the California Institute of Technology and his MBA in pharmaceutical studies from Fairleigh Dickinson University. Dr. Trust has recently formed a regulatory, quality and medical writing consultation firm, PharmExpertise, LLC, with Cellceutix becoming one of its first clients. - See more at: http://cellceutix.com/cellceutix-retains-form...pLwZz.dpuf
Even if this is a re-direction all in all it shouldn't take much to prove superiority. But to me it is a big deal to compete against what some think is the best rather than a dog that's just been sitting there.
just a couple of my notes...
vancomycin and clindamycin ~ something to look into
https://www.morningstar.com/news/pr-news-wire...print.html
http://www.duratatherapeutics.com/news-media/...tm-for-the
When brilacidin came up against more competition last month with the label change on dalbavancin I think that put the wheels in motion. Pretty confident that the majority believe we have already beaten daptomyacin.
Here is an excellent key to keep in mind...
... Dr. Trust has more than four decades of pharmaceutical research and development experience, including senior positions in R&D at Pfizer, Enzon, Wyeth/Lederle, and most recently, Allergan plc affiliate Durata Therapeutics. He has made significant contributions leading to the FDA approval of 11 drugs and supplements, including five antibacterial agents, most notably the blockbuster ZITHROMAX® (azithromycin) and most recently DALVANCE® (dalbavancin) for ABSSSI. An organic chemist by training, Dr. Trust received his PhD in chemistry from the California Institute of Technology and his MBA in pharmaceutical studies from Fairleigh Dickinson University. Dr. Trust has recently formed a regulatory, quality and medical writing consultation firm, PharmExpertise, LLC, with Cellceutix becoming one of its first clients. - See more at: http://cellceutix.com/cellceutix-retains-form...pLwZz.dpuf
Even if this is a re-direction all in all it shouldn't take much to prove superiority. But to me it is a big deal to compete against what some think is the best rather than a dog that's just been sitting there.
just a couple of my notes...
vancomycin and clindamycin ~ something to look into
https://www.morningstar.com/news/pr-news-wire...print.html
http://www.duratatherapeutics.com/news-media/...tm-for-the
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