jeffrey williams - whitehouse.gov...product rationale safety and toxicity of nicotine and propylene...

Jeffrey Williams Co-Founder amp CEO

e-Nicotine Technology Inc jwilliamsenicotinetechnologycom

+9258762765

OMB Meeting- 18 Dec2013

Key Points

1 e-Nicotine Technology (eNT) is a science-based company founded by pharmaceutical industry executives with no ties to the tobacco industry

2 Our innovative technology can reduce smoking urges almost immediately while delivering a fraction of the nicotine of a cigarette and none of the carcinogens

3 eNT has met with the CTP and they agree with our development plan

4 However forcing products like ours down a PMTA or MRTP pathway will push innovations like ours- including the job creation taxation and public health benefits- overseas

OMB Meeting- 18 Dec2013 e-Nicotine Technology Inc 2

Our Mission

eNT is a healthcare company committed to

reducing the harm associated with tobacco products by delivering nicotine aerosols with carefully controlled particle sizes to enable deep lung delivery and thus rapid nicotine

delivery helping individuals transition from

smoking


We are changing nicotine delivery from this

OMB Meeting-18 Dec2013 e-Nicotine Technology Inc 4

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Using Our Innovative Nicotine Delivery Technology

Reusable controller

Consumable dose cartridge with 500shy1000 inhalations)

Deep lung delivery of nicotine

Proprietary eHealth tools to help smokers reach their goals


Pharmaceutical Experienced Management Team

Personnel

Jeffrey Williams 25 CEO

Michael Hufford 20 CMO

PhD

Martin Wensley 25 CTO

History

bull Startedseveraldrugdelivery andmiddotmedical devicll companies

bullRaised over$500Minprivateand public capital

bull iRECrlliting ancl buildi[l~organizations~c successful exits

bull Nicotine and smoking cessation expert bull FDA-approval (Savellareg milnacipran)

more than 100 publications amp patents bull 19 years experience in application

development for mobile computing

bull8 devices moved into clinicor commercialized

bullbullExperienced developing products under FDA and other federal regul(ltOry agencies(eg FAA)

bull 47 issued patents

ALEXZAmiddot Summit Life Science Partners

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Experienced Commercial Product Experienced BOD I Investors

~anner bull Don Watkins (Chair)

bull Rich Brenner

bull Fraser Bullock

bull Chris Munday

bull Jeff Williams HandStands bull

bull Michael Hufford PhD

LifE SCIENCE 1NCiE S Jnveslino For I ffc


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OMB 1leeting -18 Dec2013 e-1Jicotine Technology Inc 10

Data Driven eNT-101 Clinical Trial

Ascending Dose Seqt~ence

Group 1 Placebo Practice H ~nKa~alions llno l

Group 2 Vehicle (1 mg pmpylene glycol) Practice H Inhalations 1- 10 j

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GroiiiiIIB 250 ~ Practice I J L_Zj~ lnhalati~~s 1 -f11() l to Determune MTDRandomization

SafetyNllper ------------ Group 4 500 ~ Prcti~~-lmiddot 50~-lnhalatiof~ltl-10l ~-+------1 toleraiiUijty liking

gmup craving reduction


Smoking Urge Change from Baseline

Baseline 1-Min Post 15-Min Post 30-Min Post

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Blood Nicotine Levels

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OMB Meeting -18 Dec2013 e-Nicotine Technology Inc 15

Key Points

L e-Nicotine Technology (eNT) is a science-based company founded by pharmaceutical industry executives with no ties to the tobacco industry





FDA Meeting Details

bull Date October lOth 2013

bull Location CTP headquarters (Rockville MD)

bull Attendees eNT- Hufford Wensley and Williams

CTP - 20+ attendees

bull Context PMTA meeting (pre-market new tobacco product)

bull Timeline

Original meeting request submitted 5-Dec-2012

- Follow-on request submitted 21-Jun-2013

- Meeting granted 26-Jul-2013

- Briefing book submitted 22-Aug-2013

- Meeting held October 10-0ct-2013


Prepared Detailed FDA Briefing Book

bull 120+ pages including Product rationale Safety and toxicity of nicotine and propylene glycol Nonclinical development plan

Clinical development plan

Abuse liability assessment plan

Quality system

Commercial device development

Risk mitigation strategy

OMB Meeting- 18 Dec2013 e-Nicotine Technology Inc

CI lhletlng B-nok iTt0000olt51)

Center for Tobacro PlOducts Meeting Meeting Information ~dltage for

e-Nicotine Technologys Plamted Premarket Tobacro Prodnet Application

(PMTA)

October ]Om 20B

e-Nicotine Iecbnologyt Inc B512ampAimreeAw

Vmper UF IW02tl

Cootwt lfamplael K Hltffurd PhD ChiefMedkm Officer e-~eTeclrnology

409 E Wirrmore Avenue ChOipcl Hill NC275l6 (919)244-2514- office (919) 869-]416- fux mimlXtrdeniootinetechnologyrom

_Niirolill TltChnol)gy Cnnfolemkd Pagel DfiZJ

18

CTP Agreed with our Development Plan for Approval as a PMTA

bull CTP provided very

helpful input on our

development plan

and the research

plan outlined in the

application appears

reasonable

f~ DEPARTMENFOlllffiALTH amp H(MAN SERVICfS

Food amd Drug Mmlroistrn~ Cerrter fuO Tobacoo Prod~~gtcts 9200 Coltpltgtrate Boulevard RockvllleMD~g

Nnvember 26 2(llJ MEEHNG MINUTES

SubmiSsion Tracking Numberr (STN) TC0000551

e-Nicotine Tcduwogy AHeattno~~ Micbael Hufford PhD Chief Medical Otlicer 4(9 E Winmore Avenue Chapel Hit NC27516

Dear Di lfuffurd

flcase refer trr you~ December 5 2012 meeling requesl to discuss the development path ofyour cletronicoirotim delivery device (ENDD) currently designated as the eNT-100 iDhakr

A copy oflfucofficial minutes of tile meeting held ou October 10 2013 is attached fur your information Please notifY us ofany significant differences in understanding regarding the meetingolrtctlmes

lfyou have anyqtWStions call Paul Aguilar Regulatory Health Project Manager al (240) ltllllZ-0383

SincereLy

Drgftallyslgned by David Ashley -S Date 20131110 083825 -0500

David L Ashley PhD RADM US Public HeaJth Service Director Office ofScience Center for Tobacco Products

Endcsure Meeting Minutes


Key Points




4 However forcing products like ours down a PMTA or MRTP pathway will push innovations like ours- including the job

creation taxation and public health benefits- overseas


FDA (US) vs MHRA (UK)

Population (MM)

smokers (market size)

Regular e-cig users (MM)

General regulatory attitude toward e-cigs

Overview

us 314

19 (47MM smokers)

6 (28M)

E-cigs may be harmful they may act as a

gateway to smoking among children they must be proven to be

safe and effective smokers should quit

completely

UK 63

20 (lOMM smokers)

7 (700K)

E-cigs are much safer then smoking most of their use is by smokers to help them quit they

need to be regulated but nicotine is not bad for

you



Number of studies required to approval

Type of studies

Clinical amp Nonclinical development costs

Eventual marketing claim

Manufacturing requirements

Fees for review

Time for regulatory review

Specifics

US PMTA pathway through

CTP

10+

Clinical nonclinical abuse liability health outcomes

~$14MM

None

GMP with inspection

$0

365 days

UK Medicinal product through

MHRA

1-2

PK and aerosol analysis

~$3MM

NRT for smoking cessation

GMPwith inspection

$46K

100 days

OMS Meeting- 18 Dec2013 e-Nicotine Technology inc 22


FDA longer and more costly

Numberofstudies requiredto approval

Type of studies Clinical n liability~middot

PK and aerosol analysis -ClinitalampNonclinical middotaevelopmentco~ts

Eventual marketing claim NRT for smokmg cessation

Manufacturing requirementsmiddot GMPwith inspection GMP with inspection

Fees for review $0 $46K

Time for regulatory review 36Sdays 100 days


We Do Believe ENDDs Should be Sensibly Regulated

bull Electronic Nicotine Delivery Devices (ENDDs) should receive an appropriately abbreviated and expedited review if they are shown to deliver far fewer harmful or potentially harmful constituents as compared to conventional cigarettes

bull Excessive regulation will prevent innovations in nicotine delivery to helping the US public and push jobs and taxable revenues overseas




+9258762765

OMB Meeting-18 Dec2013

Key Points






Our Mission




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Personnel



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History











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-80

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afIIampVehicle

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1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765


Our Mission




smoking




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VI


Reusable controller






Personnel



PhD


History











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bull Rich Brenner

bull Fraser Bullock

bull Chris Munday





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Key Points










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-10 -20


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bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

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-80 +-------------------------------------------------shy -90 k------------------shy

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CO CLIE bO 0 5 -so


-80

-90

-100

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-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765




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0

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Reusable controller






Personnel



PhD


History











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(Cypn~ss

ALEXZA






bull Rich Brenner

bull Fraser Bullock

bull Chris Munday





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Key Points










fiFCJIP~750~








0 t

-10 ~- _amp_______

-20 ~-IP ltII s - -30U)


-1-----~

~PBO


Es -70 +----------------------------UVl

-80 -1---------------------------shy


-90

12



-10 -20


~PGg5 -50

bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

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-80 +-------------------------------------------------shy -90 k------------------shy

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-10 1

-20

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CO CLIE bO 0 5 -so


-80

-90

-100

--shy IY 71

-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765



Reusable controller






Personnel



PhD


History











I NFI NII

A (cypress ERTEX

I l

inv

(Cypn~ss

ALEXZA






bull Rich Brenner

bull Fraser Bullock

bull Chris Munday





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Key Points










fiFCJIP~750~








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-10 ~- _amp_______

-20 ~-IP ltII s - -30U)


-1-----~

~PBO


Es -70 +----------------------------UVl

-80 -1---------------------------shy


-90

12



-10 -20


~PGg5 -50

bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

s E -7oUll)

-80 +-------------------------------------------------shy -90 k------------------shy

-100




-10 1

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CO CLIE bO 0 5 -so


-80

-90

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--shy IY 71

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afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765



Personnel



PhD


History











I NFI NII

A (cypress ERTEX

I l

inv

(Cypn~ss

ALEXZA






bull Rich Brenner

bull Fraser Bullock

bull Chris Munday





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Key Points










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-10 ~- _amp_______

-20 ~-IP ltII s - -30U)


-1-----~

~PBO


Es -70 +----------------------------UVl

-80 -1---------------------------shy


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-10 -20


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bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

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-80 +-------------------------------------------------shy -90 k------------------shy

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-10 1

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CO CLIE bO 0 5 -so


-80

-90

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afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765




bull Rich Brenner

bull Fraser Bullock

bull Chris Munday





z nmiddot 0

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0

~ ro I OJ ltro

lt 0 () cbull

l OJ-middot OQ ~

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Key Points










fiFCJIP~750~








0 t

-10 ~- _amp_______

-20 ~-IP ltII s - -30U)


-1-----~

~PBO


Es -70 +----------------------------UVl

-80 -1---------------------------shy


-90

12



-10 -20


~PGg5 -50

bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

s E -7oUll)

-80 +-------------------------------------------------shy -90 k------------------shy

-100




-10 1

-20

CLI c - -30 -1-----shy=vt ~ ru - -40

CO CLIE bO 0 5 -so


-80

-90

-100

--shy IY 71

-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765


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Key Points










fiFCJIP~750~








0 t

-10 ~- _amp_______

-20 ~-IP ltII s - -30U)


-1-----~

~PBO


Es -70 +----------------------------UVl

-80 -1---------------------------shy


-90

12



-10 -20


~PGg5 -50

bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

s E -7oUll)

-80 +-------------------------------------------------shy -90 k------------------shy

-100




-10 1

-20

CLI c - -30 -1-----shy=vt ~ ru - -40

CO CLIE bO 0 5 -so


-80

-90

-100

--shy IY 71

-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765


Key Points










fiFCJIP~750~








0 t

-10 ~- _amp_______

-20 ~-IP ltII s - -30U)


-1-----~

~PBO


Es -70 +----------------------------UVl

-80 -1---------------------------shy


-90

12



-10 -20


~PGg5 -50

bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

s E -7oUll)

-80 +-------------------------------------------------shy -90 k------------------shy

-100




-10 1

-20

CLI c - -30 -1-----shy=vt ~ ru - -40

CO CLIE bO 0 5 -so


-80

-90

-100

--shy IY 71

-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765






fiFCJIP~750~








0 t

-10 ~- _amp_______

-20 ~-IP ltII s - -30U)


-1-----~

~PBO


Es -70 +----------------------------UVl

-80 -1---------------------------shy


-90

12



-10 -20


~PGg5 -50

bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

s E -7oUll)

-80 +-------------------------------------------------shy -90 k------------------shy

-100




-10 1

-20

CLI c - -30 -1-----shy=vt ~ ru - -40

CO CLIE bO 0 5 -so


-80

-90

-100

--shy IY 71

-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765




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-10 -20


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bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

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-80 +-------------------------------------------------shy -90 k------------------shy

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-10 1

-20

CLI c - -30 -1-----shy=vt ~ ru - -40

CO CLIE bO 0 5 -so


-80

-90

-100

--shy IY 71

-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765




-10 -20


~PGg5 -50

bO ~~-----c~ res o ~ ~ -60 ______________________________________________________

s E -7oUll)

-80 +-------------------------------------------------shy -90 k------------------shy

-100




-10 1

-20

CLI c - -30 -1-----shy=vt ~ ru - -40

CO CLIE bO 0 5 -so


-80

-90

-100

--shy IY 71

-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765




-10 1

-20

CLI c - -30 -1-----shy=vt ~ ru - -40

CO CLIE bO 0 5 -so


-80

-90

-100

--shy IY 71

-+PBO

afIIampVehicle

lllt-soo meg (25)



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765



4






1

0


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765


Key Points






FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765


FDA Meeting Details




CTP - 20+ attendees


bull Timeline











Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765






Quality system







(PMTA)

October ]Om 20B


Vmper UF IW02tl




18




development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765





development plan

and the research


application appears

reasonable






Dear Di lfuffurd




SincereLy





Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765


Key Points








Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765



Population (MM)




Overview

us 314

19 (47MM smokers)

6 (28M)




completely

UK 63

20 (lOMM smokers)

7 (700K)



you




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765




Type of studies




Fees for review


Specifics


CTP

10+


~$14MM

None

GMP with inspection

$0

365 days


MHRA

1-2


~$3MM


GMPwith inspection

$46K

100 days


















+9258762765


















+9258762765


jeffrey williams - whitehouse.gov...product rationale safety and toxicity of nicotine and propylene...

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