TELESTA THERAPEUTICS INC T.TST

RE: Either in the midst of a deal or we are Fkkd

[Jasl]

This is in response to your email dated May 20, 2012 concerning a vaccine to eradicate Ecoli.

Before a drug product can be considered for approval, sufficient scientific evidence must be collected to show that it is safe, efficacious and of suitable quality. This scientific evidence includes results from human clinical trials.

For clinical trials in Canada, a Clinical Trial Application must be filed to Health Canada. When a manufacturer believes that they have sufficient scientific evidence about the drug product to support its market approval, they can file a New Drug Submission (NDS) for approval. Health Canada does not compel manufacturers to file a new drug submission or to file for a new indication for an already authorized drug product. It is up to the manufacturere to contact Health Canada.

Please let us know if we can be of further assistance.

__________________________________________________
Office of Regulatory Affairs
Bureau des affaires réglementaires
Biologics and Genetic Therapies Directorate
Direction des produits biologiques et thérapies génétiques
1st Floor, Health Protection Building, A.L.0701B
200 Tunney's Pasture Driveway
Ottawa, ON
K1A 0K9
E-mail: [e-mail]

This was originally sent to the Prime Ministers Office who then sent it to Minister of Health and this the response from our Government.

JASL