This is why having the before and after endoscopic
Post# of 72447
(Total Views: 362)
Posted On: 03/15/2017 2:47:28 PM
This is why having the before and after endoscopic videos of each patient is so important for B-UP.
Celgene paid "$2.6bn ($710m upfront plus $1.9bn in regulatory/development & sales milestones, plus tiered single-digit royalties)" for Mongersen (GED-0301), a potential treatment for Crohn's Disease. Their Phase 2 data were very impressive, but Celgene had to go back to Phase 1 after the deal.
"The recent steps taken by Celgene are also of concern. Given the striking PhII data that they must have seen at the time of the Nogra licensing deal, one would assume a rapid push into pivotal PhIII studies by the company. This has not yet materialised. Indeed the only trial relating to GED-0301 currently registered with either US or EU clinical trial regulators is NCT02367183, a confusingly-designated ‘Phase I‘ study examining endoscopic responses to the highest dose (160mg) of Mongersen in approximately 48 CD patient subjects who will undergo differing therapy regimens. Unlike the PhII study this trial will include (alongside CDAI) an endoscopic confirmation of active disease at enrolment , with primary and secondary outcome measures of reduction in signs of endoscopic disease and CDAI, respectively."
https://lifescicle.wordpress.com/2015/03/26/m...t-bet-yet/
There wont' be any concerns for B-UP. Great trial design by management.
Celgene paid "$2.6bn ($710m upfront plus $1.9bn in regulatory/development & sales milestones, plus tiered single-digit royalties)" for Mongersen (GED-0301), a potential treatment for Crohn's Disease. Their Phase 2 data were very impressive, but Celgene had to go back to Phase 1 after the deal.
"The recent steps taken by Celgene are also of concern. Given the striking PhII data that they must have seen at the time of the Nogra licensing deal, one would assume a rapid push into pivotal PhIII studies by the company. This has not yet materialised. Indeed the only trial relating to GED-0301 currently registered with either US or EU clinical trial regulators is NCT02367183, a confusingly-designated ‘Phase I‘ study examining endoscopic responses to the highest dose (160mg) of Mongersen in approximately 48 CD patient subjects who will undergo differing therapy regimens. Unlike the PhII study this trial will include (alongside CDAI) an endoscopic confirmation of active disease at enrolment , with primary and secondary outcome measures of reduction in signs of endoscopic disease and CDAI, respectively."
https://lifescicle.wordpress.com/2015/03/26/m...t-bet-yet/
There wont' be any concerns for B-UP. Great trial design by management.
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