We Can’t Wait Action Meeting with the FDA

Latest Update

We’ve received a response to our June 4 letter to the FDA. Read the response here.

We have responded to their letter in a blog post that includes our next steps.

Our President and CEO Calaneet Balas also wrote a guest opinion in STAT News on the FDA that you can view HERE.

Follow-up Letter to the FDA

We delivered a letter to the FDA on Friday, June 4. In our letter, we requested that the agency:

  • Issue a clear statement about its willingness to apply the flexibility described within the 2019 Guidance document.
  • Commit to providing the ALS community with a detailed report about how it has been implementing the Guidance since it was issued.

As we made clear to the FDA, we simply cannot accept a world where people with ALS have to continually go before the agency to make our case again and again.

Read the Letter (PDF)

We Can't Wait Action Meeting

On May 25, 2021, representatives from the FDA were on hand to hear from the ALS community on its urgent need for expedited access to experimental therapies.

What We Heard

Perspectives from People Living with ALS

View more than 150 responses to a questionnaire that was opened to the ALS community in advance of the May 25, 2021 We Can’t Wait Action meeting with the FDA and industry officials. These perspectives provide a clear picture of the urgency action the community is seeking to accelerate access to potentially beneficial therapies.

View the Responses (PDF)

Related Items

Read more here about our urgent calls to action to FDA and the pharmaceutical industry.

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