fda

  1. lgelb

    Sativex (THC+CBD mouth spray) shows spasticity effect in ALS, PLS

    Info on the Phase II trial here. It is on the market already in the UK for MS spasticity. The manufacturer, GW Pharmaceuticals, is negotiating with the FDA toward a US approval, having recently obtained approval for a CBD oral solution for certain forms of epilepsy.
  2. lgelb

    Public data on RCH4/NDX peptides

    Posting this public data separately from the current RCH4 thread as it may explain why controlled trials are doubtful as per today's posts, and provide some history. I'm not going to make this an open thread as there is enough rancor in the other RCH4 thread. For more links or clarification --...
  3. B

    Diaphragm Pacer

    Hello all. I'm currently using non-invasive Trilogy and Cough Assist devices, and I'm scheduled for PEG surgery on August 9. At my PEG consult yeterday, the doctor asked me if I had heard of diaphragm pacing system that's sometimes considered as non-invasive devices become less effective. My...
  4. lgelb

    FDA approves Xeomin for drooling

    It's similar to Botox but may have some safety advantages, and is the only agent with this indication, so that may make reimbursement easier to obtain.
  5. R

    ALS FDA Trials Guidance Opinion Questionnaire

    This questionnaire was written by individuals with ALS. The results will be used to relay the needs and opinions of People with ALS to the ALS Association and FDA in regards to the recently issued FDA Guidance Document. Please make your voice heard. It will only be open for a few days since...
  6. Nikki J

    Stem cell “clinics”

    This is an illustration of the fallacy of nothing to lose by trying. We always advise people who ask not to go to stem cell for pay clinics. These people did not have MND but this story shows how tragic results can be from unproven “ treatments”. There are PALS who have lost various...
  7. J

    Feasibility study for new drug

    let's say there are 5 [email protected] statistic data say less ([email protected]), but there are many poor, old, sick from other diseases etc. it means that there are on earth max 500000 pals (according to official data 100-200000). 90% cannot afford themselves drug which is permanent and cost (lets...
  8. R

    Urgent Action Item - FDA Draft Guidance for ALS

    The FDA has issued its draft guidance and we are in the comments period. The guidance is not acceptable in the opinion of many of us. It "strongly recommends that sponsors conduct randomized, placebo-coltrolled, double-blind studies..." "Historically controlled trials for ALS are strongly...
  9. P

    Boondoggle

    Is Radicava turning out to be one of the biggest FDA Boondoggles ever? I am being hammered with phone calls and emails to sign up for this drug. My doctor believes there is not enough information yet. It seems strange to me the approval and distribution of this drug is based on an Asian study of...
  10. J

    Entering 4th year of ALS - my status, pleace advice

    in a 750000 citizens capital of my country, i found just one guy (early twenties) who has ALS. he was in china, hardly speaking and moving etc so i dont have base to compare with him. there are at least more than 15 people having ALS in my town, but for sure they dont use internet. as i said...
Top