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Sherry just sent a very good post on this !

Look for it , she explains it all for ya!

Best

Lucinda

America's Favorite Herb Shop!

Glenbrook Farms Herbs and Such

Bulk Herbs, Spices, Teas, Essential oils

www.glenbrookfarm.com/herbs

_____

From: [mailto: ]

On Behalf Of anitajoy4067

Sent: Saturday, June 17, 2006 12:25 AM

Subject: FDA Guidelines

Hi,

Where are these FDA Guidelines for our bath products? Do we have to

research their websites to find out what is required to use and not;

to put on labels and what is ok?

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Thank you sooo much. I was hoping that I didn't ask a silly question being new

to bath and body products.

too2bizymom@... wrote: here are some helpful links..

I added the Florida one as I used to live there and they have some different

guidlines...

FDA cosmetic labeling manual: _http://www.cfsan.fda.gov/~dms/cos-lab3.html_

(http://www.cfsan.fda.gov/~dms/cos-lab3.html)

Actual Title 21: _http://www.cfsan.fda.gov/~dms/cos-cfr.html_

(http://www.cfsan.fda.gov/~dms/cos-cfr.html)

Legal Cosmetic Colors:

_http://www.accessdata.fda.gov/script...cfm?CFRPart=82_

(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=8\

2)

Cosmetic Ingredient Review Safety Findings:

_http://www.cir-safety.org/findings.shtml_

(http://www.cir-safety.org/findings.shtml)

Florida Cosmetic Regulations:

_http://www.doh.state.fl.us/pharmacy/...(JAN2004).html_

(http://www.doh.state.fl.us/pharmacy/WebPage/htmlwebpages/CosmeticRegulation(JAN\

2004).html)

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  • 4 years later...
Guest guest

YEs, each physician has his/her own policy. However the advent of anaphylaxis in

patients taking omalizumab has been observed in post market reporting, at around

0.2%. The Omalizumab Joint Task Force (OJTF) was put together in 2007, and put

out the recommendation,

" The OJTF recommends that patients be kept under observation for 30 minutes

after each injection. This time should be extended for 2 hours for the first 3

injections based on the data reviewed by the OJTF, as well as suggested in the

2007 National Heart, Lung, and Blood Institute Expert Panel Report 3

‘‘Guidelines for the diagnosis and management of asthma.’’3 However,

this could be modified based on a physician’s clinical judgment after

discussing risks with the patient. "

There are no FDA guidelines, but there is the NHLBI (as stated above) guidelines

that came out in early 2007. This is the third iteration of the guidelines. In

these guidelines it is stated:

" Urticaria and anaphylactic reactions have been reported in 0.1 percent of cases

(Berger et al.

2003; FDA 2003; Holgate et al. 2004; Lanier et al. 2003). Postmarketing surveys

have identified

anaphylaxis in an estimated 0.2 percent of treated patients, which resulted in

an FDA alert (FDA

2007). Most of these reactions occurred within 2 hours of the omalizumab

injection, and after

the first, second, or third injections. However, reactions have occurred after

many injections

and after many hours. Therefore, clinicians who administer omalizumab are

advised to be

prepared and equipped for the identification and treatment of anaphylaxis that

may occur, to

observe patients for an appropriate period of time following each injection (the

optimal length of

the observation is not established), and to educate patients about the risks of

anaphylaxis and

how to recognize and treat it if it occurs (e.g., using prescription auto

injectors for emergency

self-treatment, and seeking immediate medical care) (FDA 2007). "

The biggest problem with the drug omalizumab (Xolair) is that its incidence of

anaphylaxis does not appear to have any predictable pattern of incidence or

severity (other than most cases happen in the first two hours of injection).

Because of some esoteric meat allergy, appears to maybe prime the patient to

have an anaphylactic reaction to Xolair, which can happen on the first injection

(something unexpected in the world of allergy/immunology). It's quite a concern

amongst practitioners.

It is in their (practitioners) to not let the patient go home on Xolair for fear

of an anaphylactic reaction, with untoward consequences, and be at risk for

subsequent litigation.

Glenn

________________________________

From: Queen of the Universe <cleptisvirgo@...>

Sent: Fri, July 2, 2010 1:17:13 PM

Subject: [ ] FDA Guidelines

I find it interesting that everyone's doctor has a slightly different policy,

yet they ALL site FDA guidelines as the reason. Do the guidelines change every

five minutes? Or are they rather broad, allowing each doctor to pick and choose?

Mine makes me show up and check in before they mix it, which takes about 30

minutes. They used to take my blood pressure before they would mix the Xolair.

They usually ask if I have my epi pen, but I don't have to show them. Sometimes

they make me look at a printed thing about warnings, usually not. One of the

nurses asks a lot of questions, but she's new. Then I have to wait 30 minutes.

I wish they would let me inject at home!! There is a dentist office on the first

floor by the elevator I have to take and sometimes the smells coming from it are

so bad that my lungs freak out. I have to be really careful not to appear sick

or I won't get my shot. Which is stupid, because that's when I need it most.

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I guess that's what's really bugging me about the whole thing of Xolair patient

delivery - there's no uniform practice - and the differences are not due to

special needs in patients. Obviously it has nothing to do with the FDA. It's

the old power trip syndrome with patient well being at the bottom and $$$ at the

top.

It would be cheaper for the insurance companies and the patients too if they

were allowed to inject at home. But, the health care providers (sometimes an

oxymoron in my opinion) would not get the $ for providing a service I didn't

need. I suspect that part of it is also an interest in collecting data - but

without really advising the patient clearly and repeatedly as to what they're

doing.

I'm about to see an ENT due to white stuff on my tonsils, chronic cough, and

frequent sinus headaches. This was pretty much eliminated while on Xolair

(although unfortunately the number of infections increased I think which of

course created more respiratory problems temporarily). Since ENT's are

basically in a surgical specialty it is a fool's errand - surgery does not cure

allergies and due to other complications I will not have surgery. I don't need

it anyway.

--- In , " Queen of the Universe " <cleptisvirgo@...>

wrote:

>

> I find it interesting that everyone's doctor has a slightly different policy,

yet they ALL site FDA guidelines as the reason. Do the guidelines change every

five minutes? Or are they rather broad, allowing each doctor to pick and choose?

>

> Mine makes me show up and check in before they mix it, which takes about 30

minutes. They used to take my blood pressure before they would mix the Xolair.

They usually ask if I have my epi pen, but I don't have to show them. Sometimes

they make me look at a printed thing about warnings, usually not. One of the

nurses asks a lot of questions, but she's new. Then I have to wait 30 minutes.

>

> I wish they would let me inject at home!! There is a dentist office on the

first floor by the elevator I have to take and sometimes the smells coming from

it are so bad that my lungs freak out. I have to be really careful not to appear

sick or I won't get my shot. Which is stupid, because that's when I need it

most.

>

>

>

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Guest guest

What is " quite a concern amongst practitioners " ? The limited chance of an

anaphylactic reaction in a patient population that has a higher than normal

chance of an anaphylactic reaction to " typical " allergens? The fact that there's

(at least currently) no predictable pattern in the cases of anaphylactic

reaction that have been reported? The possibility that the practioner might get

sued if a patient experiences an adverse effect outside the clinical setting?

Granted, I've only talked to 4 physicians about this issue, as well as a

specialty care pharmacist, but these very few seem more concerned that their

patients who really need Xolair won't be able to get it or won't take it, and

that they (the patients) face greater (sometimes multiple) risks continuing on

repeated or consistent high doses of prednisone to lower their risk of a

life-threatening allergic reaction.

This makes me think of how the AAAAI folks came out after the most recent

recommendations by the FDA regarding salmeterol and actually held a press

conference stating how concerned they were that patients who need salmeterol in

combination with an ICS would be denied access to a medication that they need.

It's really critical that the patient conduct a thorough risk/benefits analysis

with the physician.

Lastly, if an anaphylactic attack occurs many hours after an administration of

Xolair, how can one be certain the attack is attributable to Xolair?

Addy

Group Co-owner

>

> YEs, each physician has his/her own policy. However the advent of anaphylaxis

in patients taking omalizumab has been observed in post market reporting, at

around 0.2%. The Omalizumab Joint Task Force (OJTF) was put together in 2007,

and put out the recommendation,

>

> " The OJTF recommends that patients be kept under observation for 30 minutes

after each injection. This time should be extended for 2 hours for the first 3

injections based on the data reviewed by the OJTF, as well as suggested in the

2007 National Heart, Lung, and Blood Institute Expert Panel Report 3

‘‘Guidelines for the diagnosis and management of asthma.’’3 However,

this could be modified based on a physician’s clinical judgment after

discussing risks with the patient. "

>

> There are no FDA guidelines, but there is the NHLBI (as stated above)

guidelines that came out in early 2007. This is the third iteration of the

guidelines. In these guidelines it is stated:

>

> " Urticaria and anaphylactic reactions have been reported in 0.1 percent of

cases (Berger et al.

> 2003; FDA 2003; Holgate et al. 2004; Lanier et al. 2003). Postmarketing

surveys have identified

> anaphylaxis in an estimated 0.2 percent of treated patients, which resulted in

an FDA alert (FDA

> 2007). Most of these reactions occurred within 2 hours of the omalizumab

injection, and after

> the first, second, or third injections. However, reactions have occurred after

many injections

> and after many hours. Therefore, clinicians who administer omalizumab are

advised to be

> prepared and equipped for the identification and treatment of anaphylaxis that

may occur, to

> observe patients for an appropriate period of time following each injection

(the optimal length of

> the observation is not established), and to educate patients about the risks

of anaphylaxis and

> how to recognize and treat it if it occurs (e.g., using prescription auto

injectors for emergency

> self-treatment, and seeking immediate medical care) (FDA 2007). "

>

> The biggest problem with the drug omalizumab (Xolair) is that its incidence of

anaphylaxis does not appear to have any predictable pattern of incidence or

severity (other than most cases happen in the first two hours of injection).

Because of some esoteric meat allergy, appears to maybe prime the patient to

have an anaphylactic reaction to Xolair, which can happen on the first injection

(something unexpected in the world of allergy/immunology). It's quite a concern

amongst practitioners.

>

> It is in their (practitioners) to not let the patient go home on Xolair for

fear of an anaphylactic reaction, with untoward consequences, and be at risk for

subsequent litigation.

>

> Glenn

>

>

>

>

>

> ________________________________

> From: Queen of the Universe <cleptisvirgo@...>

>

> Sent: Fri, July 2, 2010 1:17:13 PM

> Subject: [ ] FDA Guidelines

>

>

> I find it interesting that everyone's doctor has a slightly different policy,

yet they ALL site FDA guidelines as the reason. Do the guidelines change every

five minutes? Or are they rather broad, allowing each doctor to pick and choose?

>

> Mine makes me show up and check in before they mix it, which takes about 30

minutes. They used to take my blood pressure before they would mix the Xolair.

They usually ask if I have my epi pen, but I don't have to show them. Sometimes

they make me look at a printed thing about warnings, usually not. One of the

nurses asks a lot of questions, but she's new. Then I have to wait 30 minutes.

>

> I wish they would let me inject at home!! There is a dentist office on the

first floor by the elevator I have to take and sometimes the smells coming from

it are so bad that my lungs freak out. I have to be really careful not to appear

sick or I won't get my shot. Which is stupid, because that's when I need it

most.

>

>

>

>

>

>

>

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Guest guest

read below. bear in mind my previous email was not in defense of the

recommendations by the OJTF and what the EPR3 guidelines say. I was merely

reporting WHY practitioners adopt these methods.

The safest maneuver a practitioner can do is inconvenience the patient once or

twice a month, versus running the risk of the patient having anaphylactic shock

at home, going to the hospital, and in the worst case scenario having frank

hypotensive shock and airway collapse, and all resulting in the practitioner

losing his/her license with a heavy $$$ lawsuit on his/her hands.

Read below for my response to your paragraphs.

________________________________

From: pyle456 <jamcculloch2@...>

Sent: Fri, July 2, 2010 5:22:54 PM

Subject: [ ] Re: FDA Guidelines

What is " quite a concern amongst practitioners " ? The limited chance of an

anaphylactic reaction in a patient population that has a higher than normal

chance of an anaphylactic reaction to " typical " allergens? The fact that there's

(at least currently) no predictable pattern in the cases of anaphylactic

reaction that have been reported? The possibility that the practioner might get

sued if a patient experiences an adverse effect outside the clinical setting?

>>>bear in mind that i don't disagree with you. the risk for anaphylaxis is very

low. but it's " quite a concern amongst pracitioners " because the very issue of

anaphylaxis attributable to a drug being adminstered by the physician is now en

vogue.

Granted, I've only talked to 4 physicians about this issue, as well as a

specialty care pharmacist, but these very few seem more concerned that their

patients who really need Xolair won't be able to get it or won't take it, and

that they (the patients) face greater (sometimes multiple) risks continuing on

repeated or consistent high doses of prednisone to lower their risk of a

life-threatening allergic reaction.

>>>I am a PharmD in asthma/allergy practice and research, with a focus on

monoclonal antibody therapy, and have done a lot of reading in this subject. I

am as concerned as any about the availability of the drug to the patient. I have

grave concerns for patients who may have to abate their omalizumab treatment,

and go on extended courses of systemic corticosteroid therapy succumbing to

their disastrous side effects.

This makes me think of how the AAAAI folks came out after the most recent

recommendations by the FDA regarding salmeterol and actually held a press

conference stating how concerned they were that patients who need salmeterol in

combination with an ICS would be denied access to a medication that they need.

It's really critical that the patient conduct a thorough risk/benefits analysis

with the physician.

>>>yes, agreed -- i know those people, and they are quite upset (as am I) about

the turn of events from the results of the SMART and SNS trials. It's a freaking

disaster. The issue has been meta-analyzed to death. The sheer fact of it is,

asthma mortality has gone down since the advent of combination therapy in the

US. (0.9 per 100000 in 1979 steady rise to 1.7 per 100000 in 1999. Advair came

out in 2000, and the mortality in asthma has sharply dropped to 1.1 per 100000

in 2007).

Lastly, if an anaphylactic attack occurs many hours after an administration of

Xolair, how can one be certain the attack is attributable to Xolair?

>>> all cases were reviewed by the OJTF, and there were a lot of deliberations

about what was considered anaphylaxis, and the cause of which. I recommend to

look up the OJTF papers written by , et al.

>>Glenn

Addy

Group Co-owner

>

> YEs, each physician has his/her own policy. However the advent of anaphylaxis

in patients taking omalizumab has been observed in post market reporting, at

around 0.2%. The Omalizumab Joint Task Force (OJTF) was put together in 2007,

and put out the recommendation,

>

> " The OJTF recommends that patients be kept under observation for 30 minutes

after each injection. This time should be extended for 2 hours for the first 3

injections based on the data reviewed by the OJTF, as well as suggested in the

2007 National Heart, Lung, and Blood Institute Expert Panel Report 3

‘‘Guidelines for the diagnosis and management of

asthma.’’3 However, this could be modified based on a

physician’s clinical judgment after discussing risks with the patient. "

>

> There are no FDA guidelines, but there is the NHLBI (as stated above)

guidelines that came out in early 2007. This is the third iteration of the

guidelines. In these guidelines it is stated:

>

> " Urticaria and anaphylactic reactions have been reported in 0.1 percent of

cases (Berger et al.

> 2003; FDA 2003; Holgate et al. 2004; Lanier et al. 2003). Postmarketing

surveys have identified

> anaphylaxis in an estimated 0.2 percent of treated patients, which resulted in

an FDA alert (FDA

> 2007). Most of these reactions occurred within 2 hours of the omalizumab

injection, and after

> the first, second, or third injections. However, reactions have occurred after

many injections

> and after many hours. Therefore, clinicians who administer omalizumab are

advised to be

> prepared and equipped for the identification and treatment of anaphylaxis that

may occur, to

> observe patients for an appropriate period of time following each injection

(the optimal length of

> the observation is not established), and to educate patients about the risks

of anaphylaxis and

> how to recognize and treat it if it occurs (e.g., using prescription auto

injectors for emergency

> self-treatment, and seeking immediate medical care) (FDA 2007). "

>

> The biggest problem with the drug omalizumab (Xolair) is that its incidence of

anaphylaxis does not appear to have any predictable pattern of incidence or

severity (other than most cases happen in the first two hours of injection).

Because of some esoteric meat allergy, appears to maybe prime the patient to

have an anaphylactic reaction to Xolair, which can happen on the first injection

(something unexpected in the world of allergy/immunology). It's quite a concern

amongst practitioners.

>

> It is in their (practitioners) to not let the patient go home on Xolair for

fear of an anaphylactic reaction, with untoward consequences, and be at risk for

subsequent litigation.

>

> Glenn

>

>

>

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Guest guest

I asked my GP if I could receive my xolair shots at their office several moths

back due to an issue with the staff (which has since been remedied) at my

asthma/immumologist's office. She said she would except her malpractice

wouldn't cover it. She had asked around about it at a conference and was told

by a few colleagues that it's extremely rare for a bad reaction to xolair, but

when it goes bad it goes VERY bad and does so VERY quick (as opposed to a

typical anaphylactic reaction).

>

> YEs, each physician has his/her own policy. However the advent of anaphylaxis

in patients taking omalizumab has been observed in post market reporting, at

around 0.2%. The Omalizumab Joint Task Force (OJTF) was put together in 2007,

and put out the recommendation,

>

> " The OJTF recommends that patients be kept under observation for 30 minutes

after each injection. This time should be extended for 2 hours for the first 3

injections based on the data reviewed by the OJTF, as well as suggested in the

2007 National Heart, Lung, and Blood Institute Expert Panel Report 3

‘‘Guidelines for the diagnosis and management of asthma.’’3 However,

this could be modified based on a physician’s clinical judgment after

discussing risks with the patient. "

>

> There are no FDA guidelines, but there is the NHLBI (as stated above)

guidelines that came out in early 2007. This is the third iteration of the

guidelines. In these guidelines it is stated:

>

> " Urticaria and anaphylactic reactions have been reported in 0.1 percent of

cases (Berger et al.

> 2003; FDA 2003; Holgate et al. 2004; Lanier et al. 2003). Postmarketing

surveys have identified

> anaphylaxis in an estimated 0.2 percent of treated patients, which resulted in

an FDA alert (FDA

> 2007). Most of these reactions occurred within 2 hours of the omalizumab

injection, and after

> the first, second, or third injections. However, reactions have occurred after

many injections

> and after many hours. Therefore, clinicians who administer omalizumab are

advised to be

> prepared and equipped for the identification and treatment of anaphylaxis that

may occur, to

> observe patients for an appropriate period of time following each injection

(the optimal length of

> the observation is not established), and to educate patients about the risks

of anaphylaxis and

> how to recognize and treat it if it occurs (e.g., using prescription auto

injectors for emergency

> self-treatment, and seeking immediate medical care) (FDA 2007). "

>

> The biggest problem with the drug omalizumab (Xolair) is that its incidence of

anaphylaxis does not appear to have any predictable pattern of incidence or

severity (other than most cases happen in the first two hours of injection).

Because of some esoteric meat allergy, appears to maybe prime the patient to

have an anaphylactic reaction to Xolair, which can happen on the first injection

(something unexpected in the world of allergy/immunology). It's quite a concern

amongst practitioners.

>

> It is in their (practitioners) to not let the patient go home on Xolair for

fear of an anaphylactic reaction, with untoward consequences, and be at risk for

subsequent litigation.

>

> Glenn

>

>

>

>

>

> ________________________________

> From: Queen of the Universe <cleptisvirgo@...>

>

> Sent: Fri, July 2, 2010 1:17:13 PM

> Subject: [ ] FDA Guidelines

>

>

> I find it interesting that everyone's doctor has a slightly different policy,

yet they ALL site FDA guidelines as the reason. Do the guidelines change every

five minutes? Or are they rather broad, allowing each doctor to pick and choose?

>

> Mine makes me show up and check in before they mix it, which takes about 30

minutes. They used to take my blood pressure before they would mix the Xolair.

They usually ask if I have my epi pen, but I don't have to show them. Sometimes

they make me look at a printed thing about warnings, usually not. One of the

nurses asks a lot of questions, but she's new. Then I have to wait 30 minutes.

>

> I wish they would let me inject at home!! There is a dentist office on the

first floor by the elevator I have to take and sometimes the smells coming from

it are so bad that my lungs freak out. I have to be really careful not to appear

sick or I won't get my shot. Which is stupid, because that's when I need it

most.

>

>

>

>

>

>

>

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Guest guest

Glen,

Thanks for all your input. It is good to have a professional PharmD in the group

to help us understand better.

Personally, I am most willing to take that very small chance of having a

reaction to Xolair. If I were not on it, I would be on 40 mg of Prednisone daily

once again and my body wreaking more havoc from it.

If I ever DID have a reaction, I have two epi pens at my side for the full day

of the shots. No, I would not like to have to use them but as I said above I

don't mind taking my chances.

Once again thanks,

Doug

Group founder

This September, on Xolair 7 years.

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Guest guest

Hi There Doug,

Glad to provide input to the discussion when I can. When I worked at National

Jewish in Colorado, I provided a steroid kinetics/dynamics service, where we

would give patients a dose of prednisone and draw blood at certain times. We

were looking for mechanisms of steroid resistance. Point is, we would have

patients come in from all over the US, and the majority were on long term high

dose prednisone (or other corticosteorid therapy), and their long term side

effects were plain disastrous. I did most of the work when Xolair was just

approved, and some of the patients began to benefit from the drug to decrease

their steroid dependence. Just from the point of view for abating long term

steroid side effects leading to costly bad complications (i.e. a hip fracture

because of secondary osteoporosis from high dose long term pred therapy) could

be avoided, is worth the cost of the drug alone.

I agree about the home injections to an extent. I feel that as long as the

physician goes over with the patient thorough explanation of the risk of

anaphylaxis, and gives the patient an epipen (which is recommended anyhow), and

a good step-by-step instruction if the patient begins to experience anaphylaxis,

and also have the patient sign a consent form/waiver, then home injections

should be possible.

Hope you had a pleasant 4th,

Glenn

________________________________

From: Ol Wheezy <uca79iii@...>

Sent: Sun, July 4, 2010 8:55:12 AM

Subject: [ ] Re: FDA Guidelines

Glen,

Thanks for all your input. It is good to have a professional PharmD in the group

to help us understand better.

Personally, I am most willing to take that very small chance of having a

reaction to Xolair. If I were not on it, I would be on 40 mg of Prednisone daily

once again and my body wreaking more havoc from it.

If I ever DID have a reaction, I have two epi pens at my side for the full day

of the shots. No, I would not like to have to use them but as I said above I

don't mind taking my chances.

Once again thanks,

Doug

Group founder

This September, on Xolair 7 years.

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Guest guest

>

>

>

> Hi There Doug,

> Glad to provide input to the discussion when I can. When I worked at National

Jewish in Colorado, I provided a steroid kinetics/dynamics service, where we

would give patients a dose of prednisone and draw blood at certain times. We

were looking for mechanisms of steroid resistance. Point is, we would have

patients come in from all over the US, and the majority were on long term high

dose prednisone (or other corticosteorid therapy), and their long term side

effects were plain disastrous. I did most of the work when Xolair was just

approved, and some of the patients began to benefit from the drug to decrease

their steroid dependence. Just from the point of view for abating long term

steroid side effects leading to costly bad complications (i.e. a hip fracture

because of secondary osteoporosis from high dose long term pred therapy) could

be avoided, is worth the cost of the drug alone.

>

> I agree about the home injections to an extent. I feel that as long as the

physician goes over with the patient thorough explanation of the risk of

anaphylaxis, and gives the patient an epipen (which is recommended anyhow), and

a good step-by-step instruction if the patient begins to experience anaphylaxis,

and also have the patient sign a consent form/waiver, then home injections

should be possible.

>

> Hope you had a pleasant 4th,

> Glenn

>

Thanks Glenn,

I wish my doctor saw it that way LOL! :)

Doug

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