Avid Bioservices Inc (CDMO)

[Protector]

Threes you may...

Again CP

this a hundred times more but pls inform yourselves before you throw out the wrong conclusions.

The FDA has the Break-Through program than can even APPROVE based on PRE-CLINICAL trials. They don't do that lightly but there are drugs, such as Bavituximab and several others, that HAVE proven safety and hence would allow for BT designation with reduced risk. Also after PI or PII can the FDA do this. The full regulation is public. New regulation to speed it up even more is in the works (after multi-lateral talks between BP and T-administration, was posted on here).

Since IO is a player and PS-targeting yields good results (remember the FDA saw Bavituximab performance and KNOWS that Docetaxel does NOT perform in the clinic in the exceptional way it performed in out control arms) and KOLs and institutions such as MSK are getting behind it Bavi could qualify. What is MORE Bavituximab is NOT positioned as a CANCER Drug in the MONO-THERAPY and it is after tuning the MOA not even positioned as a CANCER drug perse. It is positioned as a substance that FACILITATES the main cancer drugs (Chemo/Radio/Immuno...) to work for a larger FOOT PRINT of patients and and immune response to the mix while increasing the fight against infections which for cancer patients is critical to contain the side effects as much as possible.

So see it as a catalyst in chemistry, it doesn't do the job but it makes other atoms or molecules do it.

So your TIME & MONEY argument doesn't hold IMO.