Re: Tasigna (AMN-107) Approval?

[Guest guest]

Follow up to my own question by digging around the internet... I read

somewhere (an obscure place, maybe a stock insider analyst?) that

Novartis hopes to have it approved by the FDA by July 29th, 2007.

Can't confirm this with any other source (FDA, federal register, etc.)

but at least it gives me hope that it will be approved soon barring

any monkey wrenches dropped into the cogs. If someone else can

confirm, please post it. Regards,

>

> Anybody hear or read anything new about the FDA Tasigna approval

> schedule? I know they applied in November 2006 and it got orphan drug

> status approval in March 2007. If it goes anything like Sprycel did,

> it should be in June or July of this year? Any kinks, rumbles or

> rumours would be greatly appreciated. Call me a sub-optimal response

> and waiting... DX 9/2003 800 mg/d gleevec.

>

[Guest guest]

Hi

Not so sure about that date, I just come from my

doctor and had to sign a new batch of forms my group

want to be able to increase or decrease the drug when

it needs to be..

I started out at 800 and due to a side effect was

dropped to 400 my doctor has been trying to get me

upped again, So as I said I had to sign new release

forms, not sure if this indicates a july release or

are they testing me further even tho the drug will be

released. I think they like to push the limit with

me

SkipD

--- rfarc <k0vq@...> wrote:

> Follow up to my own question by digging around the

> internet... I read

> somewhere (an obscure place, maybe a stock insider

> analyst?) that

> Novartis hopes to have it approved by the FDA by

> July 29th, 2007.

> Can't confirm this with any other source (FDA,

> federal register, etc.)

> but at least it gives me hope that it will be

> approved soon barring

> any monkey wrenches dropped into the cogs. If

> someone else can

> confirm, please post it. Regards,

>

>

>

> >

> > Anybody hear or read anything new about the FDA

> Tasigna approval

> > schedule? I know they applied in November 2006 and

> it got orphan drug

> > status approval in March 2007. If it goes anything

> like Sprycel did,

> > it should be in June or July of this year? Any

> kinks, rumbles or

> > rumours would be greatly appreciated. Call me a

> sub-optimal response

> > and waiting... DX 9/2003 800 mg/d gleevec.

> >

>

>

>

SkipD

Dx'ed Dec 1978

on Myleran(busulfan) 26 yrs

on Hydroxyurea for about 1 year

on Gleevec for approx 1.5 years

on AMN107(Nilotinib) to now

________________________________________________________________________________\

____

Sick sense of humor? Visit TV's

Comedy with an Edge to see what's on, when.

http://tv./collections/222

[Guest guest]

Hi Skip,

Keep in mind that drugs usually get approved in the US long before

they get approved in Canada. I'm sure we're still quite a way away

from its approval here but it is possible that the US will approve it

this year.

Tracey

> > >

> > > Anybody hear or read anything new about the FDA

> > Tasigna approval

> > > schedule? I know they applied in November 2006 and

> > it got orphan drug

> > > status approval in March 2007. If it goes anything

> > like Sprycel did,

> > > it should be in June or July of this year? Any

> > kinks, rumbles or

> > > rumours would be greatly appreciated. Call me a

> > sub-optimal response

> > > and waiting... DX 9/2003 800 mg/d gleevec.

> > >

> >

> >

> >

>

>

> SkipD

> Dx'ed Dec 1978

> on Myleran(busulfan) 26 yrs

> on Hydroxyurea for about 1 year

> on Gleevec for approx 1.5 years

> on AMN107(Nilotinib) to now

>

>

>

>

______________________________________________________________________

______________

> Sick sense of humor? Visit TV's

> Comedy with an Edge to see what's on, when.

> http://tv./collections/222

>

[Guest guest]

I just had an appointment with my doctor yesterday, and he said that

it wasn't due out until September. Hope that helps!

gillian

> > > >

> > > > Anybody hear or read anything new about the FDA

> > > Tasigna approval

> > > > schedule? I know they applied in November 2006 and

> > > it got orphan drug

> > > > status approval in March 2007. If it goes anything

> > > like Sprycel did,

> > > > it should be in June or July of this year? Any

> > > kinks, rumbles or

> > > > rumours would be greatly appreciated. Call me a

> > > sub-optimal response

> > > > and waiting... DX 9/2003 800 mg/d gleevec.

> > > >

> > >

> > >

> > >

> >

> >

> > SkipD

> > Dx'ed Dec 1978

> > on Myleran(busulfan) 26 yrs

> > on Hydroxyurea for about 1 year

> > on Gleevec for approx 1.5 years

> > on AMN107(Nilotinib) to now

> >

> >

> >

> >

>

_____________________________________________________________________

_

> ______________

> > Sick sense of humor? Visit TV's

> > Comedy with an Edge to see what's on, when.

> > http://tv./collections/222

> >

>

[Guest guest]

Hi Gillian,

Is this in the US or in Canada?

Tracey

> > > > >

> > > > > Anybody hear or read anything new about the FDA

> > > > Tasigna approval

> > > > > schedule? I know they applied in November 2006 and

> > > > it got orphan drug

> > > > > status approval in March 2007. If it goes anything

> > > > like Sprycel did,

> > > > > it should be in June or July of this year? Any

> > > > kinks, rumbles or

> > > > > rumours would be greatly appreciated. Call me a

> > > > sub-optimal response

> > > > > and waiting... DX 9/2003 800 mg/d gleevec.

> > > > >

> > > >

> > > >

> > > >

> > >

> > >

> > > SkipD

> > > Dx'ed Dec 1978

> > > on Myleran(busulfan) 26 yrs

> > > on Hydroxyurea for about 1 year

> > > on Gleevec for approx 1.5 years

> > > on AMN107(Nilotinib) to now

> > >

> > >

> > >

> > >

> >

>

_____________________________________________________________________

> _

> > ______________

> > > Sick sense of humor? Visit TV's

> > > Comedy with an Edge to see what's on, when.

> > > http://tv./collections/222

> > >

> >

>