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Posted On: 11/23/2020 3:26:51 PM
Post# of 148899
CDiddy,
You beat me to the punch with the trial timelines, thanks for posting them.
As always, some of what has been said in (and of) today's Proactive video demands a closer analysis.
293 Interim / Full Enrollment Overlap
In the video, Dr.NP talks about an interesting scenario that all of the team members are discussing relating to enrolling the whole trial before the interim analysis is completed because the last interim patient had to go to 42 days. I could be mistaken, but I believe he is suggesting a scenario where the fully-enrolled patients have completed the 28-day trial BEFORE the Interim 293 patients have completed the 42-day "look" requested by the DSMC.
Video Clip Excerpt: https://youtu.be/i98QF1HNXCE?t=133
As you have pointed out, this seems unlikely unless the data processing and readout take longer than your estimates.
On another topic, Dr.NP indicated that HOPEFULLY they will generate 2-3 million vials next year. These production numbers have been all over the place this year, including the promise at the end of April of 5 million vials by August or September.
Source Link: https://investorshangout.com/post/view?id=574...z6Kue5Q7h5
Regarding our ability (or not) to order additional 2021 production, let's not forget that we were told that Samsung's production capacity had become fully-booked for calendar 2020 -- by ~July of 2020.
If we are granted an EUA or Approval in January 2021, Samsung may already be booked out until June 2021. If Samsung has production capacity using other bioreactors in the same or similar facilities, it will be interesting to learn if the FDA will allow them to be used without having gone through process validation and process characterization (typically 1-1/2 years). The same question might apply to Lonza, if they are brought into the fold.
You beat me to the punch with the trial timelines, thanks for posting them.
As always, some of what has been said in (and of) today's Proactive video demands a closer analysis.
293 Interim / Full Enrollment Overlap
In the video, Dr.NP talks about an interesting scenario that all of the team members are discussing relating to enrolling the whole trial before the interim analysis is completed because the last interim patient had to go to 42 days. I could be mistaken, but I believe he is suggesting a scenario where the fully-enrolled patients have completed the 28-day trial BEFORE the Interim 293 patients have completed the 42-day "look" requested by the DSMC.
Video Clip Excerpt: https://youtu.be/i98QF1HNXCE?t=133
As you have pointed out, this seems unlikely unless the data processing and readout take longer than your estimates.
Quote:Production
CD12 75% Interim enrollment complete 11/23.
28 day endpoint completion 12/21 (est readout 1/04/2021)
42 day endpoint completion 01/04/2021 (est readout 01/18/2021)
Estimated enrollment of 390 (based on current average of 2+ per day) 01/07/2021
28 day endpoint completion 02/04/2021 (est readout 02/14/2021)
42 day endpoint completion 02/18/2021 (est readout 03/04/2021)
On another topic, Dr.NP indicated that HOPEFULLY they will generate 2-3 million vials next year. These production numbers have been all over the place this year, including the promise at the end of April of 5 million vials by August or September.
Source Link: https://investorshangout.com/post/view?id=574...z6Kue5Q7h5
Regarding our ability (or not) to order additional 2021 production, let's not forget that we were told that Samsung's production capacity had become fully-booked for calendar 2020 -- by ~July of 2020.
If we are granted an EUA or Approval in January 2021, Samsung may already be booked out until June 2021. If Samsung has production capacity using other bioreactors in the same or similar facilities, it will be interesting to learn if the FDA will allow them to be used without having gone through process validation and process characterization (typically 1-1/2 years). The same question might apply to Lonza, if they are brought into the fold.
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