Replies to post #3836 on Seneca Biopharma Inc fka SNCA

[Seel]

We are talking about two different things. I am talking about the eligibility criteria trial description written by the researchers and CUR, submitted to and approved by the FDA, allowing the company to conduct the trial. Go to clinicaltrials.gov and read their ph2 trial criteria. This is what they used beginning to end. Any participant change during trial had to be FDA approved and would be found under 'changes' on the page. When we're talking about a trial and its criteria, generally it is this source we're referring to - the approved trial itself.
You are talking about the refinement of identifying target population characterisitics that is part of the phase 1 and 2 trial process and is used to create eligibility criteria for the phase 3 study.
Two different parts of the same goal.
And yes, they are refining the data now to further refine the characteristics unique to their responders and those unique to their nonresponders. They are working to be able to know the characteristics of who this will work on and who it might harm. You say "the criteria was mixed and rightly so". I think you mean the population was mixed, which, according to the study criteria, it was: "Subjects with sporadic or familial ALS, meeting the definition of laboratory-supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial Criteria (Appendix A)." That description creates opportunity for much inclusion. They also said subjects should be within 24 months of onset. But they didn't have to be or else they would have written that differently. They gave themselves a little wiggle room there. Go read the criteria for the study. Its important to get if at the source and to know it for every biotech you're in.
Refinement of the characteristics unique to responders, or, improved identification of target population, is indeed the work of early phase research(this is what you call 'finding the criteria'). With it, they will be able to successfully create the eligibility criteria for inclusion in later studies, creating a chance for a positive phase 3 outcome.