Avid Bioservices Inc (CDMO)

[exwannabe]

How about lack of pursuing due to limited resources. Is that a condition for an extension?

I assume you are joking, but no.

The rule is:

. Up to 5 years past original expiration [or 14 years post approval if that is less, but that will not apply here].
. All time when FDA is "on the clock" counts.
. Sponsor time (trials and regulatory prep) counts as 50%
. "idle" time does not count at all.

In this case, they will easily hit the 5 years maximum, so it is moot.

The unknown on the original issue is which (if any) of the later patents will hold up and be able to block any competition. This is often fought out in Court, and I doubt even North would offer a certain answer either way.

Still, speed counts. That is why a cut of a program handed off to BP is likely more valuable than 100% of a program in their own hands. Also, partnering it off avoids the dillutive overhead of the development program that is needed at some point.