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MikeHerp

FDA takes only 30 days to approve first Crispr trial in vivo in humans

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iFdUp

Greats news ! 

Just what I have been believing and hoping for. The FDA truly is under good direction. 

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JHenry
4 hours ago, MikeHerp said:

Don’t know whether you can open this link.

https://www.ft.com/content/0fbf0604-1df5-11ea-97df-cc63de1d73f4

But the key take away is that the FDA quickly approved the first in human body Crispr trial. FDA will not be an obstacle to developing gene editing treatments. 

“If an edit misses its target, it could disrupt the genome, resulting in mutations and potentially causing cancer. But accuracy rates have improved and Editas obtained FDA approval for its first trials within 30 days, suggesting that the regulator did not require extra time to deliberate.”

 

Thanks Mike!  You’re update is much appreciated.  Henry

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LightafterDarkness
Posted (edited)

Great news. A couple of thoughts on this:

  • This is game changing technology and the FDA / the United States does not want to fall behind here. This tech is the antibiotics of our generation and when developed people wont remember what the world was like before. Remember that antibiotics is ~70 years old and most people dont remember a world where this was not for granted. As a result I dont see the FDA being a blocker especially in relation to global competition with other countries like China.
  • That said we have to hope that we dont see a Jess Gelsinger event again- that put a chill on gene therapy trials. Speed is good within reason

https://en.wikipedia.org/wiki/Jesse_Gelsinger

Edited by LightafterDarkness

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hopeful22
14 hours ago, MikeHerp said:

Don’t know whether you can open this link.

https://www.ft.com/content/0fbf0604-1df5-11ea-97df-cc63de1d73f4

But the key take away is that the FDA quickly approved the first in human body Crispr trial. FDA will not be an obstacle to developing gene editing treatments. 

“If an edit misses its target, it could disrupt the genome, resulting in mutations and potentially causing cancer. But accuracy rates have improved and Editas obtained FDA approval for its first trials within 30 days, suggesting that the regulator did not require extra time to deliberate.”

 

@MikeHerp Thank you Mike for this update, It actually made me tear up. I am so excited to read this. This helped make my day a lot better. Thank you. 

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Franny

This is the best new I have had in a long time... thank you for sharing Mike, I am so excited about this, I really hope everything ends well with the study, this gave me a lot of hope! Thanks also for the letter you sent to te Jerome lab y will make a donation as well and send a letter too. I big hug!

Franny. 

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MikeHerp
On 1/10/2020 at 10:59 AM, Franny said:

y will make a donation as well and send a letter too. I big hug!

Franny. 

Thanks!  That would be great.  I've signed up for monthly donations.  Please also consider that--if you can.  It doesn't have to be a lot.  Could be something very small every month.

If enough people do that, we might be able to get this further expedited.  

Thanks for your support.  

 

Edited by MikeHerp

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Notgivinguphope

This is really great news. Really gives me hope. I just donated again and have now signed up for monthly donations :) 

thank you!

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