| | | its really been amazing at how informative this board has been over the years, and how its turned to so much speculation based on things which are opaque to all of us.
What I know. IMMU got a CRL. CRL's often don't give the level of detail needed for a company to map out the specifics steps needed to gain approval. So IMMU mgmt will request a meeting with FDA, but BEFORE they do this, they'll make sure the agenda is the most useful it can be. The questions they need answers for will be asked in a manner to get clear responses and develop the project map they need.
This is not the time for IMMU to act rashly or question the FDA's process.
Something in the process was missed. Perhaps the FDA clearly set the goalpost in one spot, but IMMU mgmt interpreted it was in another spot. Maybe FDA moved the goalpost without informing IMMU. I don't know and I'm not assuming.
I do know the next steps are critical to IMMU and 132. I trust mgmt to respond with both calm heads and a sense of urgency. This isn't the first setback for much of this mgmt team, but they know its a big deal and the next steps won't carry much room for error. Either for IMMU or the mgmt team, which effectively has two strikes against it (this miss might have been strike three for some mgmt members).
As strange as it sounds, perhaps the shutdown gives IMMU a bit more time to get this next step right. I'm not certain, but I suspect the $$ used to fund the AA application are not applicable to further work by the FDA relative to 132. If so, it'll be a bit of time before IMMU and the FDA meet -- and the better job IMMU can do to prepare, the more likely the next time is better news for all stakeholders.
Its also important to keep in mind, IMMU may well go the AA path again for other indications. Getting the IMMU-FDA relationship to a better place is a worthy goal, too, and one which might be aided by this initial rejection. I've noticed many of the best relationships are formed because sides work together to solve big problems, as opposed to an 'everything goes smoothly' situation. There is silver lining potential here for many stakeholders -- save one group. The women with TNBC who need 132 today and won't get it, that is where my empathy is.
I'm sure posters up here know there is a tremendous amount of outside pressure the FDA faces on a daily basis. For starters, the major biopharmas have massive amounts of $$ invested in lobbying, lots of connections, etc. Making decisions independent of pressure is part of the FDA's DNA. If you want to try putting pressure on the FDA, I say 'good luck with that'.
For now, I'm giving mgmt a chance to carefully assess the next steps and execute on them. Getting the CRL is incredibly disappointing and IMMU lost some long term value in the process (whether the Wall St reaction was right or not). But I believe most of the story remains intact, including the core opportunity. But they must execute better in several ways (including their communication with the FDA) and I'm certain all of IMMU's knows it. |
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