Replies to post #257241 on Avid Bioservices Inc (CDMO)

[horselover45]

There have been many horse races
where after testing the winning horse's blood they got taken down for having illegal drugs in his or her system.

Since you used horse races as examples
is it possible that the control arm had drugs in their system that shouldn't have been there??

I would think that since it happens in one could also happen in the other.

Good night,
Andy

[thealias2002]

In your example,....if you made a bet your horse could run the time it ran, would you consider that valuable? (Rhetorical)

I agree the trial itself was a failure but benefit can still come from data collection.

One thing; in all of the reading I did this weekend on the BLA and NDA approval process, not once did I read a drug needed to have a 'successful' p1,2 or 3 to be approved. Instead, they settle on these first (per the FDA, link below);

"Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity."


Lastly,....please view page #19 2 and 2a. This certainly seems to suggest it's possible to acquire approval without the need of a clinical trial. But,....2a shows that multiple studies where results are consistent is a positive. (I think now of our p2/3 as having possible comparable performance based upon "performed as expected")

While I definitely respect your opinion and thoughts, it seems it IS, at a minimum, possible.

Reading link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078749.pdf