Recent content by North Georgia

Laurie, Quite a lot of hurdles. Also, my understand is the Right to Try Act does a pretty good job of bypassing FDA for ALS or terminally ill patients; and that drugs only have to pass Phase 1 for patients to be legally able to try them. BUT, the rub is, drug companies are NOT obligated to...

Stats Guy, Thanks for this. At a brief scan it looks like the law is on the right track but has too much criteria or roadblocks to make it actionable on a large scale basis. There may need to be a change in the FDA's mandate to actually free up biopharma ( make it cheaper to bring to market)...

Stats, I agree with your line of thinking. Nurown is a good example because it's basically a stem cell therapy (with proprietary growth factors). Stem cell therapies have little risk as I understand it but have not proven to be very effective with ALS in general - until Nurown engineered these...

...an example of one Physicians / PALS opinion re Nurown - that can likely be the case with other drugs over time. Thoughts ?

Good points all. I agree with you on most of your points but remain convinced that the current rather arbitrary and very lengthy process through which the FDA determines safety and efficacy needs to be improved on. We seem to have structural flaws in the process and need to incentivize...

Stats and Laurie, Good stuff. Despite setbacks in the past, (some of which Laurie references), the FDA's efficacy mandate is too broad and carries too much power -imo. Laurie, by "the R drugs' window for optimum efficacy" I think you mean the importance of starting the drugs as early on from...

Stats and Lisa, Good info - thank you for this. Lisa, you make a great point about the best strategy when dealing with the FDA. I think most in our community would agree that we deserve special treatment; and, after safety in trials is established, it should be up to pharma, doctors, and...

I think there is a recent video with Dr Silverman re NU 9 on everything als that should have some updates on trial status. The FDA has new leadership -- would be good to know what the process is for quick approvals following successful phase 2s. Seems like there may still be a major problem...

Looks promising. Seems like there are (currently) a number of promising drugs in the trial pipeline as well as promising early stage lab studies such as this. One wonders how long it might take for these (the ones that prove out) to become available to patients.

For what it's worth, I'm on Riluzole and Relyvrio -- added Nuedexta - felt like my symptoms got worse (heavier twitching, etc) - dropped it after a month (nuedexta) and seem to be better. I'm bulbar. I'm not sure about the correlation - but thought I'd share due to some of the similarities...

Nikki, Sorry - that's right - als untangled - I stand corrected - thank you !

Most ALS specialists advise not to believe the over the top hype and claims many of these alternative treatments use to sell their products. However, there are studies (including some clinical studies) from trials on supplements that show results in ALS patients -- some of which are positive in...

Benzos work but are highly addictive and can increase anxiety in some cases as they reduce and replace the natural gaba receptors so that one has to keep taking them. I had a very bad experience with them -- seizures, etc as I was tapering off. Everyone's different -- suggest being very careful...