I compared the new slides from LD Micro with those
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Posted On: 06/06/2019 3:46:17 PM
I compared the new slides from LD Micro with those at ThinkEquity from 2 May. Here are the primary differences:
Slide 7 now shows 350 mg results and 700 mg results dropped from 91% at 9 weeks to 88% at 19 weeks; 525 mg remained 95% 3 weeks later at 29 weeks.
Removed AACR CTC and test center slides (likely due to briefing time constraints.....and test center had Vanderbilt incorrectly marked on the map in North Carolina).
BLA submission changed from 3Q2019 to 2H2019. Not significant, but this is a little concerning as NP has stated August/September and September/October a time or two (I believe). Since everything hinges on combo approval, I was hoping with 525 mg results and safety data that this may move earlier and not later than worst case scenario stated as September.
Overview slide added "110 patients" on monotherapy for about one year and listed ODD and FTD statuses granted by the respective indication.
As previously noted, added in Samsung CMO deal and partnering - licensing opportunities slide.
Nothing too significant, but thought I would share with the board.
Slide 7 now shows 350 mg results and 700 mg results dropped from 91% at 9 weeks to 88% at 19 weeks; 525 mg remained 95% 3 weeks later at 29 weeks.
Removed AACR CTC and test center slides (likely due to briefing time constraints.....and test center had Vanderbilt incorrectly marked on the map in North Carolina).
BLA submission changed from 3Q2019 to 2H2019. Not significant, but this is a little concerning as NP has stated August/September and September/October a time or two (I believe). Since everything hinges on combo approval, I was hoping with 525 mg results and safety data that this may move earlier and not later than worst case scenario stated as September.
Overview slide added "110 patients" on monotherapy for about one year and listed ODD and FTD statuses granted by the respective indication.
As previously noted, added in Samsung CMO deal and partnering - licensing opportunities slide.
Nothing too significant, but thought I would share with the board.
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