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Re: loanranger post# 141370

Wednesday, 04/10/2019 5:37:50 PM

Wednesday, April 10, 2019 5:37:50 PM

Post# of 146196
I agree with you that it is the background package they are preparing now as part two. The original request included a proposed date for background package, and now they are getting ready to deliver it:

2. The date the meeting background package will be sent by the requester (see section VII. A., Timing of Meeting Package Submission). Note that meeting packages should be included with the meeting request for all Type A meetings and those Type C meetings where the objective is to facilitate early consultation on the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use.



No lying required.

It's interesting that the PR also detailed the long awaited manufacturing scale-up to kg size batches with adequate CMC for GLP tox, which some here claimed was impossible and would never ever happen - because, umm, it's a scam, or the laws of physics or something like that. Looking forward to what the FDA has to say on the matter of topical herpes cream nanoviricide development.
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