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TELESTA THERAPEUTICS INC T.TST

"Telesta Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the research, development, manufacturing and commercialization of human health products and technologies."


TSX:TST - Post by User

Comment by Frogger2on Mar 04, 2014 11:03am
202 Views
Post# 22277615

RE:Urocidin Conditional Canadian Approval Not Before Sept 2015.

RE:Urocidin Conditional Canadian Approval Not Before Sept 2015.Where did you get that information from SWNE?

When I read through this release my understanding is that further information will be submitted in June. Based on the review of this information Bioniche could be approved, if not sufficient they are looking at another year plus 60 days.
If they go the same route as the FDA then we are looking at a long process.

"In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow."



In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#J5iEwO1xrQkxohDx.99In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.

In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.

In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.

In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.

In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at
https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#cMezv2VGSmtkeHJg.99
In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at
In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#cMezv2VGSmtkeHJg.99
https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#cMezv2VGSmtkeHJg.99
In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at
In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#cMezv2VGSmtkeHJg.99
https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#cMezv2VGSmtkeHJg.99
In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at
In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#cMezv2VGSmtkeHJg.99
https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#cMezv2VGSmtkeHJg.99
In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#J5iEwO1xrQkxohDx.99In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.

In Canada, the Company is completing a clinical assessment package that will be submitted to Health Canada by the end of June. This package will address clinical questions asked by, and additional information requested by, the Canadian regulator after the Company asked if Urocidin™ may qualify under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. If Health Canada determines that the product does qualify under NOC/c, the Company would have 60 days in which to file a New Drug Submission (NDS), after which Health Canada would have approximately one year to review the NDS. If Health Canada is satisfied at the end of that review, an approval under NOC/c could follow.
Read more at https://www.stockhouse.com/companies/bullboard/t.bnc/bioniche-life-sciences-inc#cMezv2VGSmtkeHJg.99

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