Phase 3 Canines Lymphoma B Trial ( what to expect), page-80

Hi All,

What has been achieved.

Combination therapy is an important treatment modality in a serious disease setting.

Combination therapy will deliver less information in clinical effectiveness in relation to safety.


1. Investigational New Drug application to the FDA. It mentions what drug with what.

2. It mentions the rationale to treat a serious illness.

3. It mentions the strong biological action rationale for the combination. All the combination drugs have similar molecular pathway and biological steps.

4. Evidence has been provided in vivo , the model compares activity of combinations looking at durability and better toxicity profile.

5. Pathway followed so far

a. Phase 1
b. Safety

c. Dosing

d. Clinical pathology
e. Proof of Concept Phase 2
f. Factorial design as in drug ab v a v b.
g. Marketing application to FDA

h. Labelling design to FDA
i. Post marketing safety

Chat soon.