I requested of Celltex a copy of the email/letter that they recently sent to their patients. They kindly provided me a copy, which you can read here (snap shot of beginning is above). Thank you, Celltex!
I also asked Celltex some questions regarding their plan to start having patients treated in Mexico. Unfortunately, they have no comment on that at this time. I understand.
To my knowledge, Celltex also has a new trademarked slogan with which it ends its letter to patients:
“Transforming the way we think about medicine.™”
Celltex has also launched a new video that promotes their treatments. I watched it a few days ago–it’s a very well-produced advertisement. Unfortunately now it seems password protected. I have contacted Celltex and asked for the password.
The letter sent to patients is quite interesting.
The goal of the letter, in my opinion, is to reassure patients that things are OK and that Celltex has a plan for them to receive their stem cell treatments in the future.
Celltex is building a new lab using a technology developed by Biospherix. The goal is to have it open in March, which seems very fast. Getting GMP facilities certified as well as truly up and running more generally is a notoriously slow process so my guess is that late in 2013 or early 2014 is a realistic goal for the lab to actually be operational.
Celltex reports working with the Mexican equivalent of the FDA, called COFEPRIS (English version here) to work out treatment of Celltex patient’s in Mexico. This agency is widely viewed as far less strict than the FDA.
Regarding the ongoing work to setup treatments in Mexico, Celltex says:
We anticipate that we will be able to offer our stem cell therapy services to physicians in Mexico starting very soon! The winter-time trips to beautiful, sunny locations in Mexico to build these relationships have been an added benefit!
Mexico is nice! But an important question for Celltex patients to ask the company is whether it will pay for its patients to travel to Mexico to get the treatments or if this will be an added, unanticipated expense for the patients?
Celltex also mentions their ongoing relationship with the FDA:
As you know we are following FDA’s rules and requirements for “biological drugs” in order to obtain approval for our technology to be used therapeutically in the United States. This is a long, slow process but we are moving forward. We are meeting with the FDA at the beginning of March to go over our proposed clinical trial and with a positive review from them we would be launching it shortly after that meeting.
I was glad to read that Celltex is having a seminar for patients on March 14 at the Houstonian. There will also be a live weblink for those you cannot attend. This seems like a positive move and a good opportunity for patients to learn more and ask questions.
Overall, I think the letter and video are likely intended to encourage patients to feel less impatient and sooth some of their well-founded worries. Seems like a logical strategy.
I know many Celltex patients read this blog. I would say to them to keep hope, but realize that these things are going to take time. I would also encourage them to engage Celltex both generally and at the seminar. Ask probing questions. As its patients, Celltex owes you the respect of listening to your concerns and questions, and providing answers. So ask!