24th May, 2001

Mirable, Inc.
C/o Mirable Africa Limited
P.O. Box 25410
NAIROBI

Your letter dated 7th March 2001 is acknowledged and the contents therein. The following comments are made about your products.

The Board has carefully considered your request for the fast tract registration of this product and has the following observations to make.

This product still requires further development. You ate therefore Required to continue studying it until such time that enough clinical Information is generated and forwarded to the Pharmacy and Poisons Board for consideration. Because of this reason, provisional Registration of two years is granted. During this period, you are required to provide more clinical information generated from Approved health institutions.

This information will be submitted every year, failure to which registration will be revoked. You are directed to treat this product as a prescription only medicine. If the patients are not able to afford the product arrangements should be made to access the product.