We've been dealt a blow, but our resolve is unwavering
Little brother Evan making Josh & Benny crack up
At 5:27pm, this past Friday afternoon October 2nd the email came in. Jennie and I excitedly read it as soon as we saw it come through but the news was yet another blow. The FDA placed a “Continue Hold Letter” on our request and we will not be allowed to move forward with the treatment for Benny and Josh...yet.
On June 17th, the FDA first put the “IND” (investigational new drug) request on hold, even though our team had been led to believe the day before that we’d be given a green light. So you can imagine our shock and disbelief when we received the first “hold” letter.
Following two and a half months of additional experiments, writing and extensive correspondence, our team submitted a “CRH” or Complete Response to Hold on September 2nd. Throughout the process and since the submission we have remained in contact with the FDA. So while we counted down the days (and hours) until the FDA’s deadline to respond on October 2nd, we believed we’d receive good news this time around.
Adding to our hope was an email our team received Friday, September 25th. The FDA project manager emailed a request for more information that they required to be submitted by Monday, September 28th. Provided that we were able to supply this additionally requested information (which we were assured by the lead physician/researcher we would be) this had to be good news - or so we allowed ourselves to believe. When we sent our email last week, we believed that one final round of prayers would be all we would need, and by Monday, October 5th we’d be making plans for Dayton, Ohio (for the procedure for the boys which we expect to take place at Dayton’s Children’s Hospital).
Unfortunately, we are sending this update tonight to let you know the heartbreaking news...we will have to wait longer.
Our team has already scheduled a call to discuss our plan for next steps - rest assured we will not give up. We MUST save Benny and Josh and we will persevere. Your continued support has carried us through our nearly three-year journey and we will not quit now. Yes, there were tears shed this weekend over the Sukkot holiday. Yes, Jennie & I felt as if we’d been dealt a hard blow to our guts. And yes...the possibility of an extended and expensive delay weighs heavily on our hearts.
So please continue to keep our boys in your prayers. We will send another update with more information as it becomes available.
To those celebrating Sukkot we wish you a Chag Sameach, happy holiday. And to all others, wishing you a good week, with health and happiness. With Love and Gratitude,
Gary, Jennie, Michael, Benny, Josh & Evan
The boys and their Hebrew names as follows:
Shalom Binyamin & Yehoshua Natan, each ben Shayna Toyba
שלום בנימין בן שיינה טייבה ויהושע נתן בן שיינה טייבה
You can make a tax-deductible donation to “Cure Canavan Fund” HERE.
Cure Canavan Fund is a registered non-profit 501C3. All donations are tax deductible. EIN# 83-4489648