Replies to post #43577 on Ayala Pharmaceuticals Inc (ADXS)

[trading_cyclist]

My bet is that we shoot back to 10 on EMA approval. Stay tuned.

TC

[huskercatman123]

Initially here at the Cro-Magnon science camp I was personally thinking of regenerative as stem cells; but the term "cell therapy" seems very broad. But I am only guessing here; but looks like it would have to be designated as RMAT on the IND?


https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm

Here is an example of another company that obtained the RMAT designation:

https://www.streetinsider.com/Corporate+News/Athersys+%28ATHX%29+Announces+RMAT+Designation+From+FDA/13363899.html

I have not spent a great deal of time researching the 21st Century Cures Act; but it seems there are many other items that potentially apply to our products?