FDA is stalling - Summary of July 6th call with FDA - Take action!

Hope Now for ALS update: Summary of July 6th call Dear Hope Now for ALS (HNFA) supporters,  We apologize for the delayed update. We have been trying to schedule the next meeting so we could report that in this update. After our July 6 meeting, we submitted a detailed proposal to the FDA and requested a timely response, but it appears the FDA is stalling. They suddenly want to invite other “stakeholders” to our meeting. We believe this is a tactic to bring people and organizations into the discussion that will defend the status quo and to convert the role of actual PALS and CALS into a minority voice. With much regret, we need to report that after three meetings we see little evidence that the FDA is willing to be flexible with respect to clinical study designs and data analysis approaches that could accelerate the development and delivery of safe and effective medicines for ALS. WE WILL NOT ACCEPT THIS! Please write the FDA today and copy members of Congress and the media expressing your outrage that ALS is still not being treated with urgency. Demand that the FDA respond immediately to Hope Now for ALS (HNFA) in a substantive and meaningful way as they promised they would. State that you regard Hope Now for ALS as your representative for this process and that you expect the FDA to continue timely, direct discussions with HNFA on expedited and modernized development and approval pathways for ALS treatments – a 21st Century Approval Process! Please email Dr. Woodcock at the FDA:
janet.woodcock@fda.hhs.gov 
and copy the people below and your representatives and media contacts 
druginfo@fda.hhs.gov
 richard.moscicki@fda.hhs.gov 
william.dunn@fda.hhs.gov 
stephen.ostroff@fda.hhs.gov 
john.jenkins@fda.hhs.gov 
eric.bastings@fda.hhs.gov 
ronald.farkas@fda.hhs.gov
 nicholas.kozauer@fda.hhs.gov 
brad_grantz@toomey.senate.gov
 Grace_Stuntz@help.senate.gov
josephine_eckert@murray.senate.gov Summary of the July 6th conference call Our third meeting with Janet Woodcock and her staff focused on finding common ground; specifically, balancing the need for faster, less costly, more conclusive trials and the FDA’s desire to keep ineffective treatments off the market. We were able to agree on FVC (change) as a primary endpoint, and ALSFRS (change) as a secondary endpoint. The ensuing discussion focused on topics fundamental to designing quick confirmatory studies that could lead to approvals for drugs/treatments that have demonstrated safety and preliminary evidence of efficacy in Phase 1 or 2 trials. Two principal topics that emerged from this discussion were (1) use of a patient-specific ALS progression predictive algorithm to construct a virtual and homogeneous placebo trial arm designed to reduce statistical noise in trials caused by the heterogeneity of ALS; and (2) understanding where and how the FDA can show some flexibility in the use of its statistical significance standard based on calculation of a p value as the standard for establishing “efficacy.”  Achieving a p-value of