| | | I'm gonna do a quick jump into the mfg conversation (and probably regret it) since I did this, albeit a long time ago. Also been thru plenty of audits, some with direct responsibility, others which had an indirect role.
We all knew IMMU needed a culture change. A new mgmt has done that, I'm certain. Manufacturing products which require exacting standards requires the right mindset to execute properly. I'd guess the lab was designed for speed and flexibility, not meticulous mfg standards. Changing from lab to mfg is a big step.
In one audit, our company was told the conditions we were making the equipment were too lax. The truth is, lax seemed fine, it allowed us to build what we needed without any need to tighten the environment (it got tightened later on in the process). The added cost to upgrade was completely unnecessary. But the auditor made a terrific point. If we wanted to continue and grow, we needed to set a tone consistent with expectations. And by upgrading the area, we'd be taken more seriously, we'd take ourselves more seriously and do a better job of meeting the rigorous specs at high quality levels that were required. In short, our culture was too sloppy and it set the wrong expectations.
Within a week, there was a change in procedures and a change in approach. The audit turned out to be a huge benefit because it pushed our biz to make a culture change -- which was needed.
These things take time. Turning informal knowledge into specified procedures with back-up plans, testing processes, etc is a major change in culture, equipment, tracking, traceability, etc. Even the way people dress can play a role. This is both hardware and software, and anyone who's done this sort of thing (and many up here have) know its not trivial.
A lot can get done in 5 months time and I'd bet things were moving quickly before the audit which led to the Form 483. For example, I'd bet IMMU was well on its way to replacing the Excel sheets with something more robust well before the audit. I'd guess IMMU has come a long way in a hurry, but apparently not far enough.
We'll learn more, probably in drips and drabs in the days ahead. As others have suggested, we'll learn a lot about the next few quarters by how IMMU handles their staffing and their cash, in the absence of revenues.
Failing AA definitely hurts, but anyone who thought IMMU was going to be the next major biopharma and get there without growing pains was too optimistic. If IMMU is to become a major player, they need to grow up. I think we've got a leadership team which understands this, even if they missed this important milestone. |
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