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NurOwn AdComm announced in Federal Register — what’s next?


This morning, the September 27th, 2023 FDA Advisory Committee meeting regarding NurOwn (debamestrocel) was formally announced in the Federal Register.  

Here is the link to the formal notice: 

http://federalregister.gov/d/2023-15923

The docket number for the NurOwn Advisory Committee meeting is FDA–2023–N–2608

Next week, I AM ALS will release a more comprehensive guide to submitting written comments, which are due on September 20th. In your written statements, please refer to “NurOwn” as “debamestrocel,” its technical name, in your subject header. More information below.

I AM ALS will also be hosting a preparation session for those who are chosen to speak at the  NurOwn Advisory Committee meeting. 

We will notify you on social media and via newsletter when our guide and speaking event are published, but for now it is important that we quickly share with you the formal notice with the two important deadlines  — 

  • on or before 12 p.m September 12, 2023 to request a speaking opportunity at the Sept 27th Advisory Committee meeting
  • September, 20th, 2023 to have your written statement included in the official materials for the Advisory Committee panel.

What does the posting of the docket do?

Statements

The FDA posting the docket means that you can begin submitting statements to the FDA through their public portal. Here is that link:

https://www.regulations.gov

Again, the docket number is FDA–2023–N–2608.

The deadline to submit written comments that will be included in the official meeting packet of materials shared with the Advisory Committee members is September 20th.

Within your comments, you must include:

Docket No. FDA–2023–N–2608 for Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

If you don’t want to submit your comments electronically you can mail, hand deliver, courier (for written/paper submissions) to: 

Dockets Management Staff (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Speaking request for public hearing

You are also able to start submitting requests to speak at the open public hearing at the Advisory Committee meeting. 

Those requests are not first come, first serve.  

Everyone will be considered as a potential speaker until the deadline of noon (12:00 PM EST on September 12th.  If they receive too many requests, then they will use a lottery system.

If you do not have direct experience with NurOwn, please think carefully before you submit your name as a potential speaker as you could be denying a more effective speech from being selected. This isn’t to say that if you don’t have direct experience with NurOwn you should not submit, we are just asking people to take a moment to reflect before submitting their name.

To request the opportunity to speak at the hearing you must send a note to:

[email protected]

The request format is succinct:

Request for time to speak at Sep 27 CTGTAT open public hearing for debamestrocel, Docket No. FDA–2023–N–2608 for “Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”

I am requesting 5 minutes to speak at the September 27th CTGTAT meeting’s open public hearing for debamestrocel.  I will be speaking [on my own behalf/on behalf of xxxx organization]. I [will/will not] be presenting slides.  My testimony will share my experience xxxx [brief description].

Thank you.

Name:
Affiliation (if any):
Phone:
Email:
Mailing Address:

For your scheduling calendar – Oral presentations from the public will be scheduled between approximately 1:40 p.m. and 2:40 p.m. Eastern Time on September 27, 2023. This time could shift.


We will find cures for ALS. The only question is when. That answer depends on you.

Stay informed on I AM ALS’ progress and what you can do to help us make hope real.

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