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Government Shutdown May Delay FDA Approval of Zolgensma
Not something I even considered, but I just read an interesting article stating that during the government shutdown, FDA approvals will be put on hold. That would mean the FDA approval for the new treatment for Zolgensma may also be delayed as long as the government is shut down. I’m not sure what that will mean for the future trials. Hopefully they will continue as scheduled. What are your thoughts?
Here’s the link to the article I read: https://www.kare11.com/article/news/possible-lifesaving-medical-trial-on-hold-during-govt-shutdown/89-7a6b7484-9bf6-4db3-ae45-c7b5633938cd
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8 Replies
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Way to go Trump. But seriously, this is a real shame. Hopefully this administration will realize the effects of this circus show and reopen the government soon. It’s ridiculous.
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<p style=”text-align: left;”>Hi, I can’t read the article – access is denied.</p>
Could anyone post it here or send it to me per email? Thx!-
I sent you a message with the article attached. Thanks for letting me know you had difficulty with the link.
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My opinion is that Trump wants to protect US medical industry, Novartis is a Swiss company. I would like to say I’m wrong.It is all about profite and money.
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I don’t know how they choose which departments get closed in a partial shutdown, but I did notice about the FDA last week. However, I hadn’t thought about this stalemate possibly causing the Zolgensma trials to be canceled. I’m assuming they are on a strict timeframe when it comes to giving the participants whatever is necessary and recording the results on a similar timeframe. I really hope it doesn’t ruin this opportunity. I’ve been looking forward to Zolgensma becoming approved!
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Update: As the partial government shutdown continues it was brought to my attention that although the FDA is not functioning at its full capacity, drugs that were submitted before 2019 are still being reviewed and on schedule for approval. Since Zolgensma was submitted in 2018, it should be on track. Here’s the link to that article https://www.forbes.com/sites/joshuacohen/2019/01/10/partial-government-shutdowns-impact-on-fda-drug-approvals/#5d36fb732d08
I still might not eat bagged lettuce, but that’s just me.
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Thanks for the update DeAnn. Yeah it is good to hear that these drugs are still on track.
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The shutdown may delay the enrollment date for AVXS-101 trials that are supposed to open in April. Reaching out to clinical coordinators to see if I can find a definitive answer. Thanks DeAnn for the updates!
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