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eagle8

04/07/17 11:20 AM

#112151 RE: franky111 #112150


It was a screening hold. Not a hold on the trial.
The trial continued.

GLTA
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biosectinvestor

04/07/17 11:27 AM

#112155 RE: franky111 #112150

Besides the post being completely speculative and very likely unrelated, I doubt this would be the basis of putting a partial hold, not a full hold, on an entirely unrelated company, with vaccines created but not limited necessarily by date.

I think if it related to a service provider, you'd hear about a halt on a service provider and how it impacted other companies, for instance... And there would be no real reason to keep that secret, because the service provider is the ultimately liable party, so you'd actually want people to know it wasn't due to anything you did... and more importantly, it would likely be health and safety related... there was no indication that that was the case for NWBO.

So, not sure why you're linking to that letter except on a wholly speculative basis.

I am not a medical related professional. I do have enough knowledge of the regulatory process to highly doubt this is connected in any way, given what we know otherwise. Is there any reason, other than the date of the letter, that you think makes this possibly relevant? And how are you drawing the connection to NWBO? What letter or date exactly is suggesting to you these are connected events? Your explanation was not very clear.
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exwannabe

04/07/17 11:36 AM

#112160 RE: franky111 #112150

The FDA does not publicly discuss drugs in the approval process (with the sole exception of the AdComs). They do not disclose holds, they do not disclose trials, they do not disclose anything.

The form 483 you mention would be to cite a manufacturing issue, not hold a trial (though the former could cause the latter).

Furthermore, they are not released to the public. They can be requested under the FOI act, and once such are pulled they may post it. I am not certain if they will pull one for an investigational drug though, as much of that is confidential per law.

AS far as being a stretch, yes. I really, really, really doubt that LP would allow the stock PPS to be destroyed when she could just point to an unrelated supplier they happened to use.

Besides which, why not just switch to some other? All we are talking is fairly normal blood test type stuff.
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pgsd

04/07/17 12:30 PM

#112183 RE: franky111 #112150

IMHO even if there was such a problem, FDA would have ultimate responsibility to determine if the trial was in any way compromised and the fact they lifted the halt would suggest this was not the case