RE: Kutapressin question/thought/KUTAPRESSIN UPDATE

[Guest guest]

THE INFORMATION BELOW IS

THE MOST RECENT INFORMATION REGARDING THE AVAILABILITY OF KUTAPRESSIN

IT IS VERY PRELIMINARY

INFORMATION AND SHOULD NOT BE CONSIDERED FACTUAL UNTIL A FORMAL ANNOUCEMENT IS

MADE!

Our parent organization, The Parents Coalition

has been in communication with Schwarz and a major university’s

Pharmaceutical department about that University taking on the manufacturing and

distribution of Kutapressin as part of their ‘Orphan or Limited Use’

drug program. Schwarz was willing to work through the licensing transfer issues

and had essentially offered to transfer the licensing right for only the

minimal legal costs required-(Probably under 25K). However there are many

technical issues to resolve; the primary one being FDA approval via the

previous ‘Grandfathering’ of Kutapressin. In the meantime, Schwarz

had maintained communication with other organizations and Pharmas regarding the

status of Kutapressin. At this time, it appears that Schwarz is preparing to

transfer the manufacturing right to a new Pharma who will re-initialize

production and distribution of Kutapressin. The name of the Pharma who will be

taking this on HAS NOT BEEN REVEALED at this time.

PLEASE REMEMBER THAT THIS IS ONLY

PRELIMINARY INFORMATION. I HAVE NO FURTHER INFORMATION ABOUT TIMELINES.

I will update as I have information I am

able to share!

Marc Share

Executive Director

Parents Coalition

_______________________________

Re: Kutipressin

question/thought

Does

anyone know why no drug company is willing to

make kutapressin any more? It just doesn't make

sense, if there is a demand for it, why will no one

provide it? Barb

[Guest guest]

This is promising! Thanks for the info, Marc, and

please keep us updated, if you can. Barb

--- marc@... wrote:

> THE INFORMATION BELOW IS THE MOST RECENT INFORMATION

> REGARDING THE

> AVAILABILITY OF KUTAPRESSIN

> IT IS VERY PRELIMINARY INFORMATION AND SHOULD NOT BE

> CONSIDERED FACTUAL

> UNTIL A FORMAL ANNOUCEMENT IS MADE!

>

> Our parent organization, The Parents Coalition

> has been in

> communication with Schwarz and a major university's

> Pharmaceutical

> department about that University taking on the

> manufacturing and

> distribution of Kutapressin as part of their 'Orphan

> or Limited Use'

> drug program. Schwarz was willing to work through

> the licensing transfer

> issues and had essentially offered to transfer the

> licensing right for

> only the minimal legal costs required-(Probably

> under 25K). However

> there are many technical issues to resolve; the

> primary one being FDA

> approval via the previous 'Grandfathering' of

> Kutapressin. In the

> meantime, Schwarz had maintained communication with

> other organizations

> and Pharmas regarding the status of Kutapressin. At

> this time, it

> appears that Schwarz is preparing to transfer the

> manufacturing right to

> a new Pharma who will re-initialize production and

> distribution of

> Kutapressin. The name of the Pharma who will be

> taking this on HAS NOT

> BEEN REVEALED at this time.

>

> PLEASE REMEMBER THAT THIS IS ONLY PRELIMINARY

> INFORMATION. I HAVE NO

> FURTHER INFORMATION ABOUT TIMELINES.

> I will update as I have information I am able to

> share!

>

> Marc Share

> Executive Director

> Parents Coalition

> _______________________________

>

> Re: Kutipressin question/thought

>

>

> Does anyone know why no drug company is willing to

> make kutapressin any more? It just doesn't make

> sense, if there is a demand for it, why will no one

> provide it? Barb

>

>

=====

Barb Katsaros

barbkatsaros@...

[Guest guest]

,

Thanks so much for the kind words. I can take very little credit. It was

the grandmother of a child along with that family's extensive

efforts to connect the Parents Coalition to the University connection

that gave us the clout to keep the door open with Schwarz. I think the

initiation of and maintaining of on-going discussions with Schwarz was an

important component in their entire outlook in the Kutapressin matter

and was instrumental in their decision to continue discussions with other

interested Pharmas.

I urge everyone the keep in mind that this is still 'in process' and

nothing official as of yet.

Marc

PS. I would like to extend my extreme gratitude to Cheryl (1raptor) for

her dedication and assistance in compiling the scientific data/abstracts

whenever materials are needed to send out in the constant mission to connect

with additional members of the medical and scientific communities.

Her work is invaluable to the parents organization.

___________________________________________

RE: Kutapressin question/thought/KUTAPRESSIN UPDATE

Wow! Hope so much that goes through! Thank you so

much for taking on this battle, whether it goes

through or not. I know there must be a tremendous

amount of work involved in this - and a lot of

brilliance too.

--- marc@... wrote:

> THE INFORMATION BELOW IS THE MOST RECENT INFORMATION

> REGARDING THE

> AVAILABILITY OF KUTAPRESSIN

> IT IS VERY PRELIMINARY INFORMATION AND SHOULD NOT BE

> CONSIDERED FACTUAL

> UNTIL A FORMAL ANNOUCEMENT IS MADE!

>

> Our parent organization, The Parents Coalition

> has been in

> communication with Schwarz and a major university's

> Pharmaceutical

> department about that University taking on the

> manufacturing and

> distribution of Kutapressin as part of their 'Orphan

> or Limited Use'

> drug program. Schwarz was willing to work through

> the licensing transfer

> issues and had essentially offered to transfer the

> licensing right for

> only the minimal legal costs required-(Probably

> under 25K). However

> there are many technical issues to resolve; the

> primary one being FDA

> approval via the previous 'Grandfathering' of

> Kutapressin. In the

> meantime, Schwarz had maintained communication with

> other organizations

> and Pharmas regarding the status of Kutapressin. At

> this time, it

> appears that Schwarz is preparing to transfer the

> manufacturing right to

> a new Pharma who will re-initialize production and

> distribution of

> Kutapressin. The name of the Pharma who will be

> taking this on HAS NOT

> BEEN REVEALED at this time.

>

> PLEASE REMEMBER THAT THIS IS ONLY PRELIMINARY

> INFORMATION. I HAVE NO

> FURTHER INFORMATION ABOUT TIMELINES.

> I will update as I have information I am able to

> share!

>

> Marc Share

> Executive Director

> Parents Coalition

_______________________________

__________________________________

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