Replies to post #84265 on Avid Bioservices Inc (CDMO)

[geocappy1]

Biopharm- very interesting article. I especially like the part below. I like the fact that we are using MOS to determine success/failure in our trials.
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Yet they do increase the odds. According to Recap's data, 37 percent of partnered biotech drugs in non-cancer indications get from Phase I to approval, compared to 11 percent of unpartnered non-cancer drugs. Cancer is harder all around, with just 19 percent of partnered biotech drugs and 4 percent of unpartnered drugs making it.

Natanson said the problem in cancer is that most Phase II trials use tumor shrinkage endpoints that don't always translate into a survival advantage in Phase III. "That endpoint switch is a risk factor," she said, noting that non-cancer indications in general tend to have better Phase II endpoints.

Another scary statistic from the Recap analysis: The late-stage failure rate – i.e. failure in Phase III or beyond – was 69 percent for unpartnered cancer drugs versus 38 percent for those that were partnered. "Late-stage failure is the worse type of failure," Natanson said, because it is so expensive.

[volgoat]

My brother in law was at Immunex for 10 years and now at Amgen ever since the buyout years back....He has told me repeatedly, there is NO WAY to go alone once PHIII's start....Too much money, too much man power needed, and too much experience needed...A small biotech does not have any of the above...The key is to find the best partner and best deal to move the drug forward in a timely manner.
He told me last week that the main focus for Amgen is to do deals and that goes for the entire BP landscape. R&D is being cut and the trend is to find drugs that are promising and partner or buyout...
Most don't even look at anything under $100M......

As we now know, PHII looks good and warrants a PHIII....The partner will be the one designing the PHIII, so I would assume a deal will have to be done by years end, at least announced by then...Would not expect it until NOV-DEC.