The Houston Chronicle has posted the response letter from Celltex to the FDA in regard to the FDA Warning Letter issued to Celltex. The Chronicle also has a piece up on the warning letter that is a great read here. My thoughts on the possible paths for Celltex moving forward can be found here. The Celltex letter sheds further light on possible futures for the company.
While partially redacted (actually the redactions are seemingly minimal), it is fascinating reading although rather dense at times with jargon that might be hard to understand for those not deeply versed in FDA and biologics production. I found parts hard to fathom.
I’ve tried to boil it down for you into major bullet points.
- Celltex wants to meet with the FDA to talk about all the issues. That seems wise.
- The letter also further demonstrates just how deeply Celltex and RNL Bio, which runs the Celltex Texas Lab, are intertwined.
- Celltex asks the FDA to respect its operational confidentiality. Also makes sense.
- Celltex is still arguing its stem cell product is not a drug and that argument takes up the bulk of the letter, reflecting that Celltex knows this is the most crucial issue. Without seeing their actual data claiming that their cells are not changed after growth in culture in their RNL Bio-run lab it is hard to be concrete on this argument. Even so based on what I do know and on precedent, my opinion is they will most likely lose this argument.
- “Celltex has ceased patient enrollment and is closing out its 2012 clinical trials. It will work with the agency to create future clinical trials under INDs.” That’s a direct quote from the letter. What does this mean? It sure seems to suggest that the cells for transplant business is effectively on hold until it can work things out with the FDA, get INDs, get a BLA, etc. Sounds like a lot to do and time consuming steps. What happens to the company in the mean time? I don’t know.
- Interestingly, there is also a hint (at least I thought I saw one, but could be wrong) in the letter that Celltex may have interest in getting into the non-amplified stem cell treatment business as I suggested in my earlier post.
More in this great article by Todd Ackerman of the Houston Chronicle. From that piece:
“We’re telling potential patients that we will still bank their stem cells but that we can’t sponsor the required trials until we’re in compliance with the FDA,” said Andrea Ferrenz, Celltex’s executive vice president and legal counsel. “We hope that will be in a matter of months.”
So for the time being Celltex is going to be a stem cell bank. Will they transition to transplant only non-amplified stem cells ultimately?