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Re: Trial 106 - Correction

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hallo cheryl ann

as i have told lynne we have heard from one of the drs on the board of thr trial

106 that novartis has decided to keep following the patients on the gleevec arm.

the interferon arm of this trial was closed after 1 year since almost all

patients on this arm switched to gleevec.

as far as i understood the decision to continue the trial is not limited in

time. when we joined the iris trial it was planned to continue for 5 years. i am

now midway through the 6 th year.

shalom

giora

[ ] Trial 106 - Correction

Hello Lynn and Everyone,

In reviewing the information a bit closer it seems that in fact trial

106 may just well be closed. The information I have seen is that as of

their last update on their conditional approval status, which was dated

April 2003, they would have had to provide annual updates on trial 106

for three years. In January 2004, they would have provided reports for

2003, In January 2005, they would have reported 2004, and in January

2006, they would have reported for 2005 - three years.

If anyone else is getting kicked off the trial or needs assistance,

please let me know, maybe I can help put you in touch with the right

person at Novartis.

Cheers, Peace, Love and light,

Cheryl-Anne

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Hello Giora,

This is very good information and I hope it helps Lynn. It would be

good for her if they did keep the trial going. The information I am

referring to has to do with information available in the U S because

of the freedom of access to information. It shows that as far as the

FDA is concerned, in order for Novartis to fulfill their obligations

for their " conditional " approval, they had to report the outcomes of

the patients from trial 106 for three years only. Obviously it would

be neat if they kept this going as it would be good for everyone to

know.

Lets keep our fingers crossed for Lynn!

Shalom,

Cheryl-Anne

>

> hallo cheryl ann

> as i have told lynne we have heard from one of the drs on the board

of thr trial 106 that novartis has decided to keep following the

patients on the gleevec arm. the interferon arm of this trial was

closed after 1 year since almost all patients on this arm switched to

gleevec.

> as far as i understood the decision to continue the trial is not

limited in time. when we joined the iris trial it was planned to

continue for 5 years. i am now midway through the 6 th year.

> shalom

> giora

> [ ] Trial 106 - Correction

>

>

> Hello Lynn and Everyone,

>

> In reviewing the information a bit closer it seems that in fact

trial

> 106 may just well be closed. The information I have seen is that

as of

> their last update on their conditional approval status, which was

dated

> April 2003, they would have had to provide annual updates on

trial 106

> for three years. In January 2004, they would have provided

reports for

> 2003, In January 2005, they would have reported 2004, and in

January

> 2006, they would have reported for 2005 - three years.

>

> If anyone else is getting kicked off the trial or needs

assistance,

> please let me know, maybe I can help put you in touch with the

right

> person at Novartis.

>

> Cheers, Peace, Love and light,

> Cheryl-Anne

>

>

>

>

>

>

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In a message dated 2/18/2006 5:12:29 P.M. Eastern Standard Time,

cheryl.simoneau@... writes:

as i have told lynne we have heard from one of the drs on the board

of thr trial 106 that novartis has decided to keep following the

patients on the gleevec arm. the interferon arm of this trial was

closed after 1 year since almost all patients on this arm switched to

gleevec.

> as far as i understood the decision to continue the trial is not

limited in time. when we joined the iris trial it was planned to

continue for 5 years. i am now midway through

Hi, since I am very ill at the moment I have not followed up on the trial

information you gave me. I emailed but I was told to contact my trial center,

which of course doesn 't want to continue with me. I came down with some awful

dizziness and terrible nausea these past four days so I have not felt well

enough to battle with Novartis or the hospital. The hospital has not called me

either, as the person said she would last week. I don't know which end is up.

I just want to feel better so I can pursue this. Thanks everyone, Lynne A.

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