|Collectively, what we don't know about the CRL and next steps is a whole more than what we do know. |
IMMU doesn't know enough either, that's why they need the meeting. They don't know if they'll need a category 1 or 2 submission -- that itself is telling.
At this point, there are a few things people do know. There is a range of scenarios for getting 132 approved, some are a matter of months, others could run out to around a year. We have a realistic range of possibilities. We believe that the FDA believes132 works well enough to approve before the phase 3 data is complete - an approval which can be rescinded if the phs 3 results are insufficient.
We don't know the 'real-world' severity of the CMC issues raised in the CRL. Again, IMMU isn't really sure on this front. The one read into this came from Morgan Stanley. But we also know Pehl misread the tea leaves before, so even this take isn't so trustworthy.
We have the mgmt team we have. Some will trust them, some will not. The Morgan Stanley report was comforting, but they also cut the target share price (was $38 I think) more than in half ($17). And they lowered their upside forecast to $25. Did failing AA all of a sudden make 132 worth half of what it was? I don't think so. And yet, a major analyst slashed everything.
We'll know a lot more by the actions we see next. If the company goes into cash preservation mode, it means they believe this could take a while. If they get rid of Morris (the CMC guy), it means they've lost confidence in his ability to get manufacturing right. If Pehl goes, it'd suggest iMMU is up for sale -- they can't afford to be without a CEO in this period.
For me, I'm going to trust this management team, but keep my grain of salt handy. Yes they missed and the miss matters a lot. But they can correct and get the company back on track. I don't think the share price will be happy until after an approval, so I suspect IMMU is a trading stock until the FDA says 'approved' or 'not' on the next submission.
Lastly, I wondered if we'd hit 50,000 comments before IMMU got an approval or after. I'm afraid its gonna be after ...