Hi everyone,
I emailed Galagen last Friday with some questions about the 'BASICS PLUS' products. I asked if other products were in development for hospitals and nursing homes that would require modified clinical trials. I also asked him how many hospitals and nursing homes are in the U.S. I highlighted things I thought were interesting. I will copy his reply to me:
Dear Mark,
Thanks for your note and your ongoing interest in our development
program.
Selective disclosure rules prevent me from answering many of your
questions, but I can provide some general information about our
development approach.ÿ By staying tuned, you will be able to watch the
products pop out into the market.
I offer a few basic comments below, and hope that these help to guide
your thinking.
The initial Lifeway Basics Plus product is intended to support
gastrointestinal health.ÿ In general, dietary supplements can bear
claims on the label related to "structure and function" effects.ÿ There
is already a great deal of published information about positive benefits
on gastrointestinal function of the components of Basics Plus.ÿ Lifeway
will have a very attractive set of flavors and packages on the shelves
as the marketing effort proceeds.ÿ
The clinical products we are developing are different than Basics Plus
and will target specific nutritional and health challenges in hospitals
and nursing homes that affect a sizeable fraction of the residents of
these institutions.ÿ These products, by the specific benefits we hope to
achieve, will be evaluated in clinical trials and will be formulated to
address the unique serving requirements of these institutions.ÿ These
products may also have markets that extend beyond hospitals and nursing
homes--if they taste good to a patient in a nursing home, then they are
going to taste good to you and me.
One of GalaGen's core strengths is the ability to produce
pathogen-specific polyclonal antibodies, and there are multiple problem
pathogens that are found in the gastrointestinal tracts of hospital and
nursing home patients.
Published estimates of the total clinical nutrition market exceed $2
billion, and there are over 6000 hospitals and over 16,000 nursing homes
in the U.S.
Stay tuned!
Bob Hoerr
GalaGen Inc.
4001 Lexington Ave North
Arden Hills, MNÿ 55126
So to put all of that in English.
'BASICS PLUS' will be released to supermarkets and health food stores and does not require any clinical trials because it is considered a dietary supplement.
The other new products to follow are 'clinical', and will undergo clinical trials. They will target specific disease in patients of hospitals and nursing homes.
A word about the clinical trials. I spoke with the CFO of Galagen back on May 20, of this year about these clinical trials. He said that they would be a 'modified clinical trial' which takes only about 2 months to complete.
He also stated back then that they had conversations with several companies about these new products and that there could be high profits in single size servings.
It is almost 1998, which is the year I've been waiting for.
Mark |
