Biotech Values

[microcapfun]

Geron

>>But more importantly, would the FDA buy Geron's argument?<<

What argument? Geron's two PRs on the subject of the FDA hold are an exercise in obfusication.

This is what they seem to be saying in the 2nd PR. Some manufacturing runs generated too many cysts in rat spinal cords, however one run generated no cysts. We'll keep playing with the manufacturing process ...

"We are committed to the optimization of all our hESC-based products as we improve the manufacturing process and identify improved product release criteria." (Geron)

Shouldn't the manufacturing process and product release criteria have been locked down by now, at least for the Phase 1 trial? Isn't having to go back and optimize it a HUGE step backward which could set the program back years?

After all, the first time around the FDA required hundreds of rats to be followed for 9 months after treatment. It seems the least they would require is that rats be followed for 9 months using the new manufacturing process and product release criteria - once those are completely nailed down.

Think about an analogy with a therapeutic protein program. Just about the time a Phase I clinical trial is about to begin, it is found that at least one version of the therapeutic protein generates adverse effects in animals. The clinical trial is halted and the company says it is going to work on optimizing the manufacturing process, but hey - good news ... with one manufacturing run and an unknown number of rats (but plural, so at least 2!), no adverse effects were seen.

You'd say - YIKES!! That means essentially going back to square one as regards the preclinical development.

That would be the reaction if the therapeutic was a small molecule. But now consider the fact that Geron's product is first-in-FIRST-in-class! How much more picky is the FDA going to be?

In a nutshell, I think a delay of more than a year until the trial can be 're-started' is likely.

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