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LonghornSean

06/23/22 3:37 PM

#147830 RE: SC8 #147829

I don't know why I am getting in between my two biggest haters here but perhaps MK knew the FDA was going to require additional testing. Versus working everything linear MK could be working parallel paths. Maybe treatment tests on animals are underway now having projected what the FDA newbies need. The test plans have been written up waiting for approval. Maybe approval comes after the tests are completed. Shortly thereafter IDE is submitted and 30 days later it's approved. More could be happening behind the scenes than we all know. Maybe a single wink there.

RDGL
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splintered sunlight

06/27/22 10:34 AM

#147891 RE: SC8 #147829

Keeping it real is a problem around here.
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Cameron12221

06/27/22 12:45 PM

#147900 RE: SC8 #147829

I strongly disagree with those timelines for testing and everything. The fact they were in detailed discussion with JHU that early on and had such a head start along with the fact they already have a very strong working relation with them makes me think they had a great jump start. Also the fact that the FDA agree to expedite the meetings and feedback makes me believe it wont take that long. It takes roughly 2 weeks give or take to grow the VX2 Tumors. They only have to inject the product and do the imaging, then euthanize them and check for the decay. I can't imagine this taking more than week.

Also even if this speculation of every person in the world being on vacation they have also agreed to put this on a high priority so I see this being taken care of in a timely fashion relative to the process. I'm not sure if a lot of the meetings are still being held by online video calls, but that also helps make it a lot quicker and easier to get done with the FDA.