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Biotech / Medical : SANGUINE CORP. (SGNC) -- Ignore unavailable to you. Want to Upgrade?


To: Jim B who wrote (3967)9/14/1998 12:50:00 PM
From: Prospector  Read Replies (1) | Respond to of 5402
 
SHAREHOLDERS NEWS LETTER

September 4, 1998

Dear fellow shareholders:
We have heard some feedback that our phone reports of progress with the Battelle animal trials have been too conservative. I believe the fault is that we know the details of the work being done, but have not communicated them clearly to you.

The FDA has long standing, clear regulations for animal trials. 1) We must make new fresh lots of PHER-02 by GMP (Good Manufacturing Practices): 2) We must perform a series of in-Vitro tests, i.e. laboratory bench tests before injecting PHER-02 into animals: 3) We must perform animal safety trials, i.e. inject the PHER-02 into a series of healthy animals, such as mice, rats, guinea pigs, cats, dogs; and then observe the animals health for varying periods depending on species: 4) Perform autopsies on the animals to look for problems: 5) Only then do we induce disease, i.e. heart attacks, cancer, blood loss, etc., into the varying species to see if they are cured or improved. Step 5 are called the animal efficacy tests. These will take 6-9 months, before we start the human safety and efficacy trials, which will take 2-3 years.

The human trials are more difficult and costly because rather than inducing disease in an animal, we do the human efficacy trials on people who are actually sick and compare the results with humans control patients who receive a placebo.

These human efficacy trials are the ones that our competitors. Baxter, Northfield, Alliance, Somatogen, Hemosol, Biopure, have all experienced difficulties in the last 12 months. Their products are different from ours in both raw materials and manufacture. We have predicted their problems and failures. Our second generation PHER-02 should have an easier trial since the first generation passed in 1989.

Battelle is right on schedule and will send us a report in the near future.

We hope this reassures you, and are sorry for the misunderstanding.

Sincerely,

Anthony G. Hargraves ------------------ Thomas C Drees, Ph.D.
Vice President ----------- Chairman and CEO