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Reata Pharmaceuticals has given an update on their clinical development programs, including their initiation of rolling submission of NDA for Omaveloxolone for treatment for patients with Friedreich’s Ataxia.
Read the press release and more information here.
The presentation provides an update on the company’s progress in submitting the NDA and what the company is doing to prepare for the commercial space. It also contains a review of the study results on FA and Omaveloxolone.
What are your thoughts?
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For the information in my possession always talking to researchers and doctors, oveloxone could really be a turning point as well as it could do little in people with more years of Ataxia, I explain better: the drug experimentation was done on people who were “better” because they had to meet high standards, as soon as (I hope as possible) it will be marketed everyone can use it and here it is not known how it will react, it could give limited results in those who are worse than those who have experienced it but for the same reasoning it was explained to me by a researcher in Milan that it could even have more important results in those who have the disease for longer
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<span class="Y2IQFc" lang="en">Hi Davide, my brother is being treated at Carlo Besta, but he would like to change neurological institute. where are you being treated? Are the researchers following you in contact with the European research group that is collaborating in the research with omevaxolone?</span>
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I think this will be amazing when it comes out but after having FA diagnosed in 2001 ( now I am 44 and in a wheelchair full time, only balance and coordination affected touchwood) and always looking on the bright side, we have been told for many years next year next year next year and now because of the pandemic , to be honest I am getting a little disheartened as the goal post always seems to be moving there is only so much time but you can be optimistic for! Surely I cannot be the only one that is wondering how much longer the carrot will be dangled.
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Having seen how the selection was done for participants in the trial, it required someone of paralympic standard recumbant cycling ability with corresponding breathing and endurance. Whilst being hopeful and grateful for any company pursuing a treatment I do wonder how effective it will be for the vast majority that couldn’t achieve the lofty selection criteria.
Fingers crossed as anything that could just slow down or halt FA progress whilst other lines of research maybe provide better therapy or even cure would be beneficial and provide hope for the future.
I find myself comparing the speed of Covid drug repurposing and vaccine testing with the protracted testing times we have, especially for the former. I’ve never seen bespoke testing for many other drugs that are just used, say in an emergency (e.g. painkillers) or if it was a condition the drug could be used for in itself (say psoriasis for DMF…..).
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