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Re: arvitar post# 144741

Thursday, 09/17/2020 9:30:50 AM

Thursday, September 17, 2020 9:30:50 AM

Post# of 146291
There is some acceleration of the IND process for Covid, as frrol stated:

https://www.fda.gov/media/137927/download

FDA is issuing this guidance to facilitate a sponsor’s preparation of, and FDA’s review of, a pre-
IND meeting request. Well-prepared pre-IND meeting requests should enable more timely
initiation of clinical trials under an IND.

During the current public health emergency, with the large number of potential therapeutics for
COVID-19 related illness, it is essential that the review process for investigational drugs be as
efficient as possible. To facilitate this, we are urging sponsors to submit a pre-IND meeting
request that allows early and thorough review and discussion between the sponsor and FDA,
which can lead to more rapid review of the subsequent IND and assurance of subject safety,
which in turn can facilitate faster clinical trial initiation for programs that proceed to that phase.
..
For the
purposes of our response to the COVID-19 public health emergency, we are consolidating the
typical pre-IND meeting request and package development process into a single step.



Agree it's probably worth pursuing an IND for Covid. Really anything we can get into clinic I am for it. Would rather they went after topical herpes first, but perhaps the climate called for Covid development and drug, since most standard research / clinical trials have been put on hold, and just now starting up again. I know someone who runs an academic lab with 26 students and postdocs, and the only research they were allowed to do on site was Covid related. So he started some Covid projects. Either that or sit at home.
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