Could the FDA tell them to lump mTNBC into the 22

Quote:

---

Could the FDA tell them to lump mTNBC into the 22 solid tumor BTD?

---

Based on the 2nd bullet below to be discussed it sounds like they are independent of each other.

-Status of the Company’s request for Breakthrough Therapy Designation for the treatment of mTNBC with leronlimab
-Expected timing of the Company’s filing for a new request for Breakthrough Therapy Designation for the treatment of 22 different solid tumor cancers

While I agree that it sounds like it will be anticlimactic if they stay "still waiting on FDA decision".....think if they didn't even mention mTNBC BTD in the PR then people would be losing their s**t! I expect they have had some communication with the FDA and while we may not get an answer, the FDA may say if you can produce similar results in XX patients or XX weeks we will grant you BTD (and approval)! I think the results fully justify BTD and approval, but they may want to see more patients results and for a minimum period of time.

Please do your own due diligence. All my posts and comments are not to be considered investment advice.