Comments on: Dendreon to Turn in Provenge Application to FDA in Mid-November http://www.xconomy.com/seattle/2009/09/24/dendreon-to-turn-in-provenge-application-to-fda-in-mid-november/ Business + Technology in the Exponential Economy Sat, 11 Feb 2012 03:54:18 +0000 hourly 1 http://wordpress.org/?v=3.0.4 By: jerzee http://www.xconomy.com/seattle/2009/09/24/dendreon-to-turn-in-provenge-application-to-fda-in-mid-november/comment-page-1/#comment-83730 jerzee Sat, 26 Sep 2009 12:20:10 +0000 http://www.xconomy.com/?p=43016#comment-83730 Luke .... Should Mitch and company prove true to form, that is, to hold out for a peer attended event to release pertinant new data - and should historical track records mean anything at all then perhaps a quick review of old news releases may suggest a more narrow mid November date to focus in on. On the last go round Dendreon put forth the following headline with story on Monday November 13, 2006: "Dendreon Completes Submission of Biologics License Application to FDA for PROVENGE in Hormone Refractory Prostate Cancer" Just three days earlier, on Friday November 10 the company set the stage with: "Dendreon Announces New Data Analysis Presented at Chemotherapy Foundation Symposium". These headlines book ended the Symposium dates. If one were to be looking to narrow "mid-November" down to a feasible guesstimated date ... with the Chemotherapy Foundation Symposium "Innovative Cancer Therapy for Tomorrow" being convened this year in New York from November 10 - 14 ..... somewhere around there might prove to be a good time to start checking for press released top line data numbers and completion of the aBLA submission headlines. Luke ….
Should Mitch and company prove true to form, that is, to hold out for a peer attended event to release pertinant new data – and should historical track records mean anything at all then perhaps a quick review of old news releases may suggest a more narrow mid November date to focus in on.

On the last go round Dendreon put forth the following headline with story on Monday November 13, 2006: “Dendreon Completes Submission of Biologics License Application to FDA for PROVENGE in Hormone Refractory Prostate Cancer”
Just three days earlier, on Friday November 10 the company set the stage with: “Dendreon Announces New Data Analysis Presented at Chemotherapy Foundation Symposium”. These headlines book ended the Symposium dates.

If one were to be looking to narrow “mid-November” down to a feasible guesstimated date … with the Chemotherapy Foundation Symposium “Innovative Cancer Therapy for Tomorrow” being convened this year in New York from November 10 – 14 ….. somewhere around there might prove to be a good time to start checking for press released top line data numbers and completion of the aBLA submission headlines.

]]> By: Luke Timmerman http://www.xconomy.com/seattle/2009/09/24/dendreon-to-turn-in-provenge-application-to-fda-in-mid-november/comment-page-1/#comment-83618 Luke Timmerman Thu, 24 Sep 2009 17:52:26 +0000 http://www.xconomy.com/?p=43016#comment-83618 Bob--I didn't catch which phase of trial Dendreon has in mind for Neuvenge, although the earlier work was in breast cancer, and this is for bladder. I would guess this will be another Phase 1.--Luke Bob–I didn’t catch which phase of trial Dendreon has in mind for Neuvenge, although the earlier work was in breast cancer, and this is for bladder. I would guess this will be another Phase 1.–Luke

]]> By: Bob Smith http://www.xconomy.com/seattle/2009/09/24/dendreon-to-turn-in-provenge-application-to-fda-in-mid-november/comment-page-1/#comment-83615 Bob Smith Thu, 24 Sep 2009 17:41:57 +0000 http://www.xconomy.com/?p=43016#comment-83615 Luke, Will that Neuvenge trial be a Phase 1 trial? Or since they already had some phase 1 trials for it for another cancer, will it be Phase 2? Luke,
Will that Neuvenge trial be a Phase 1 trial? Or since they already had some phase 1 trials for it for another cancer, will it be Phase 2?

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