Max/GSK/FDA/Fostemsavir:
Meeting Category: Pre-NDA
Meeting Date and Time: Febrnary 28, 2018;
Meeting Location: 10903 New Hampshire Avenue
White Oak Building 22, Conference Room: 1309
Silver Spring, Maryland 20903
Application Number: IND 73916
Product Name: fostemsavir
SPONSOR ATTENDEES
ViiV Healthcare Company:
Amy Pierce Clinical Development Director
Cyril Llamoso Medical Development Leader
Karen Grainger VP, Regulatory Affairs
Margaret Gartland Clinical Development Manager
Marty St. Clair Clinical Development Director
Max Lataillade VP, Head of Clinical Development
Peter Ackerman Physician Project Leader
GlaxoSmithKline:
Bridin McCaughey Clinical Development Manager
Chris Jones Medicine and Product Delivery Team Leader
Chet Bowen Sr. Regulatory Project Manager, Nonclinical
David Chen Programming Manager
Keith Barker Safety Development Leader
Lan Nguyen Manager, Global CMC Regulatory Affairs
Mark Baumgartner Senior Director & Team Leader, Global Regulatory Affairs
Frank Mannino Director, Statistics
Mindy Magee Director, Clinical Pharmacology
Sherry Watson Regulatory Affairs Manager
MEETING PRELIMINARY COMMENTS
ViiV Healthcare Company
Attention: Sherry Watson
Regulatory Affairs Manager, GlaxoSmithKline
P.O. Box 13398
Research Triangle Park, NC 27709-3398
Dear Ms. Watson:
Please refer to your Investigational New Drug Application (IND) submitted under section 505(i)
of the Federal Food, Drug, and Cosmetic Act for fostemsavir.
1.0 BACKGROUND
The pmpose ofthe meeting is to discuss ViiV's plans to submit a New Dmg Application (NDA)
for fostemsavir tablets in 2019. In paiiicular, the Sponsor seeks agreement on the schedule and
elements for a rolling NDA review, and on the content/fonnat of their proposed NDA.
___
Although all of Fostemsavir publicity says ViiV Healthcare, this FDA IND email show GSK was 100% backing Max.
Fostemsavir is Rukobia.
The drug GSK also exclusively built mfgr'ing plants for.
All adds up being another potential tell tell sign that Max is indirectly here for a Cytodyn / GSK marriage.
With Max overseeing the structure of indications.
Which would bring us closer to answering how do you address Ohm's list of addressable indications.
Because you better believe our crew & their contacts, are 100% aware of all things CCR5.
Keep 20 - 30 of them for in-house &
license the rest?
Either way, if bring in ViiV / GSK / Pfizer, then Leronlimab has everything it needs to go global.
I believe that collaboration would feel there is so much to go around profit wise due to CCR5, that the only "debate" is, how fast can we get an Action Plan rolling.
Max was the final button that needed to be pushed, to get things in motion.
Maybe one thing we see now is an adjustment to the Pipeline page. Drop-downs added to each mention, like someone requested after it was updated.
With Max overseeing everything, that new structure is very possible.
Wow.
Who would have thought all these things possible in just the last 7-8 months.
What an amazing end of the year ahead of us.
Meeting Category: Pre-NDA
Meeting Date and Time: Febrnary 28, 2018;
Meeting Location: 10903 New Hampshire Avenue
White Oak Building 22, Conference Room: 1309
Silver Spring, Maryland 20903
Application Number: IND 73916
Product Name: fostemsavir
SPONSOR ATTENDEES
ViiV Healthcare Company:
Amy Pierce Clinical Development Director
Cyril Llamoso Medical Development Leader
Karen Grainger VP, Regulatory Affairs
Margaret Gartland Clinical Development Manager
Marty St. Clair Clinical Development Director
Max Lataillade VP, Head of Clinical Development
Peter Ackerman Physician Project Leader
GlaxoSmithKline:
Bridin McCaughey Clinical Development Manager
Chris Jones Medicine and Product Delivery Team Leader
Chet Bowen Sr. Regulatory Project Manager, Nonclinical
David Chen Programming Manager
Keith Barker Safety Development Leader
Lan Nguyen Manager, Global CMC Regulatory Affairs
Mark Baumgartner Senior Director & Team Leader, Global Regulatory Affairs
Frank Mannino Director, Statistics
Mindy Magee Director, Clinical Pharmacology
Sherry Watson Regulatory Affairs Manager
MEETING PRELIMINARY COMMENTS
ViiV Healthcare Company
Attention: Sherry Watson
Regulatory Affairs Manager, GlaxoSmithKline
P.O. Box 13398
Research Triangle Park, NC 27709-3398
Dear Ms. Watson:
Please refer to your Investigational New Drug Application (IND) submitted under section 505(i)
of the Federal Food, Drug, and Cosmetic Act for fostemsavir.
1.0 BACKGROUND
The pmpose ofthe meeting is to discuss ViiV's plans to submit a New Dmg Application (NDA)
for fostemsavir tablets in 2019. In paiiicular, the Sponsor seeks agreement on the schedule and
elements for a rolling NDA review, and on the content/fonnat of their proposed NDA.
___
Although all of Fostemsavir publicity says ViiV Healthcare, this FDA IND email show GSK was 100% backing Max.
Fostemsavir is Rukobia.
The drug GSK also exclusively built mfgr'ing plants for.
All adds up being another potential tell tell sign that Max is indirectly here for a Cytodyn / GSK marriage.
With Max overseeing the structure of indications.
Which would bring us closer to answering how do you address Ohm's list of addressable indications.
Because you better believe our crew & their contacts, are 100% aware of all things CCR5.
Keep 20 - 30 of them for in-house &
license the rest?
Either way, if bring in ViiV / GSK / Pfizer, then Leronlimab has everything it needs to go global.
I believe that collaboration would feel there is so much to go around profit wise due to CCR5, that the only "debate" is, how fast can we get an Action Plan rolling.
Max was the final button that needed to be pushed, to get things in motion.
Maybe one thing we see now is an adjustment to the Pipeline page. Drop-downs added to each mention, like someone requested after it was updated.
With Max overseeing everything, that new structure is very possible.
Wow.
Who would have thought all these things possible in just the last 7-8 months.
What an amazing end of the year ahead of us.
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