Avid Bioservices Inc (CDMO)

[chevalblanc-47]

Volgoat, I am having second thoughts.

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I think it benefits they to go to the end

I believe you are right, it has a merit to have a complete trial with 550+ patients.

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Mid to late 2017, Then add 6/12 months on top of that.

I have another opinion (or hope?) on that.


Scenario (if CP/Golfho/Tradero are correct with their assumptions):

First look-in is safety and futility. I believe we agree safety is not a concern. For futility the FDA will have a look at the how the 2 arms evented. If they see a ratio of 165 to 20, there will be a round of jaw-dropping. They can either unblind or give Peregrine a "thumbs up" to continue and wait for the second look-in.

If they unblind at first look-in they might see that doce behaved as any other doce trial, so they could stop the doce arm and take 10 months OS as given. Doce arm would get Bavi, too.

But they could still collect data on the original Bavi arm and publish interim data (every month ?) to see how far it goes.
Can you imagine Garnick every first Monday of the month giving out the Bavi Report on CNBC? In July he might say : MOS 18 months and 65% of patients still alive. Reminds me of the "orange crop report" in "Trading Places"
At any one point they could close the trial and publish the final reading.

In such a scenario we would not have to wait until 2018 to get approval. The FDA could start the process after unblinding.

Of course I don't know if the FDA operates that way. Is unblinding automatically the end of a trial? That would be even better.

How would the pps fare?
If they get "thumbs up" (they would surely do a PR) in the first look-in the pps should have a "relieve" jump. Don't forget that a few of the last look-ins of small biotechs went totally wrong.
If they unblind at first look-in with very good results, the stock will jump quite a bit. Remember: at 20$ market cap is still 25% lower than 2016 Opdivo sales. If they keep collecting data until the end of the year, the stock might jump at any positive reading.

all IMO

have a nice Sunday

danny