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    Amx0035

    Hi members, I've heard there may be movement with the fda on amx0035 from the fda, does that mean in time to come if agreed by the fda we will be entitled too receive it in the UK?

    #2
    Unless it brings dead flesh to life I'm not interested.
    Bulbar started Jan 2020. Mute and 100% tube fed but mobile and undefeated. Stay Strong 🤗😘🤗😁xx

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      #3
      Brave man stay strong sir 💪💪

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        #4
        Originally posted by Simonchip View Post
        Hi members, I've heard there may be movement with the fda on amx0035 from the fda, does that mean in time to come if agreed by the fda we will be entitled too receive it in the UK?
        Do you have any links to the info would be interested to read👍
        Initial diagnosis 7-4-2021 'suspected MND' confirmed by 2nd opinion 4th June 2021 ALS. Began with R foot limp and lots of falls. Generally weak. Mostly terrified.​​​​​​

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          #5
          Originally posted by Simonchip View Post
          ... does that mean in time to come if agreed by the fda we will be entitled too receive it in the UK?
          In a word, no.


          ​Diagnosed 03/2007. Sporadic Definite ALS/MND Spinal (hand) Onset.
          Eye gaze user - No functional limbs - No speech - Feeding tube - Overnight NIV.

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            #6
            It's time for the FDA to use the same REGULATORY FLEXIBILITY it did for AMX0035 again, and ask BrainStorm to come to the table by filing a BLA. Wilson Bryan is the head of the NurOwn review team at FDA CBER, and Peter Marks is the head of this part of the agency. As we see the FDA finally listening to Congress, the pressure must go up, not down. This video explains what happened and why. In this video, Mike explains what the heck is happening, the process involved, and WHY.
            This constant excuse from ALSA and other anti-NurOwn people in the past that "the company has to file before anything can happen" has (again) been demolished. The FDA CAN and MUST "signal" the same willingness to let a NurOwn application (BLA) be filed and get serious consideration. The data will follow. But the FDA CAN ACT NOW!

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              #7
              Ellie why do you say in a word no! If the fda release amx0035 we surely under compassionate terms be allowed drugs released by the fda why shouldn't we??

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                #8
                https://alsnewstoday.com/

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                  #9
                  LindaB The pharma company met with the FDA, who agreed in principle, to take another look at AMX0035 and allow Amylyx to submit a New Drug Application.

                  Amylyx also plan to submit an application for approval to the EMA, which, if (eventually) approved, may be more significant on what happens in the UK, rather than what the FDA does or does not do.

                  Amylyx press release xx
                  ​Diagnosed 03/2007. Sporadic Definite ALS/MND Spinal (hand) Onset.
                  Eye gaze user - No functional limbs - No speech - Feeding tube - Overnight NIV.

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                    #10
                    Originally posted by Simonchip View Post
                    If the fda release amx0035 we surely under compassionate terms be allowed drugs released by the fda why shouldn't we??
                    Ask the MHRA, not me.
                    ​Diagnosed 03/2007. Sporadic Definite ALS/MND Spinal (hand) Onset.
                    Eye gaze user - No functional limbs - No speech - Feeding tube - Overnight NIV.

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                      #11
                      So if the USA get amx0035 we may not then, it makes perfect sense

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                        #12
                        Simonchip It's important to note that it is up to the pharma company to apply to a regulatory body for a drug approval - in this case, without an application from Amylyx Pharma, AMX0035 cannot be evaluated by the MHRA, so stands zero chance of being available in the UK.

                        I am not being negative, I am being realistic and factual.
                        ​Diagnosed 03/2007. Sporadic Definite ALS/MND Spinal (hand) Onset.
                        Eye gaze user - No functional limbs - No speech - Feeding tube - Overnight NIV.

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                          #13
                          It's bewildering to me that a drug that could prolong life may not be allowed here in the UK, even under compassionate grounds, without sounding negative what have the UK or European countries have to offer, America have at some point amx0035 and hopefully nurown, tregs are on there way, what have we got???

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                            #14
                            Thanks for the links Simonchip Ellie
                            Initial diagnosis 7-4-2021 'suspected MND' confirmed by 2nd opinion 4th June 2021 ALS. Began with R foot limp and lots of falls. Generally weak. Mostly terrified.​​​​​​

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                              #15
                              Originally posted by Simonchip View Post
                              what have we got???
                              Boris...

                              ​Diagnosed 03/2007. Sporadic Definite ALS/MND Spinal (hand) Onset.
                              Eye gaze user - No functional limbs - No speech - Feeding tube - Overnight NIV.

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