Avid Bioservices Inc (CDMO)

[RRdog]

FTM,

Could you hazard a guesstimate on "time" and "hurdles" to an FDA decision on a "non therapeutic" IND re "imaging" based on similar IND non-therapeutic filings???

Could you also hazard a guesstimate on time to negotiable data points for large companies to consider partnering?? I note that some of the largest companies in the world are involved heavily in "imaging" among them GE, JNJ, ABT.

When I have talked about the size of the "imaging" market I have used a conservative figure of several billion dollars. It is interesting to note that on the PPHM web page they are raising the ante by citing studies indicating that market will be more diverse and approach 15 billion by 2015.

Lastly, could you comment on any thoughts you might have about new imaging methodology enhancing the PPHM proof of bavi activity versus cancer targets.

Thank you in advance.

RRdog

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[An exploratory IND study on a potential diagnostic radiopharmaceutical would not appear to
necessitate the following traditional dose escalation, safety, and tolerance studies due to minimal risk
from the drug substance to human subjects. FDA should waive requirement for those subsequent
studies given the clinical benefit and low risk of the drug product to humans.]