[Ip-health] Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation

Michael H Davis m.davis at csuohio.edu
Wed Mar 25 12:05:43 PDT 2020

In my experience these are always signed under oath and to misstate a material fact is perjury.


Prof. Mickey Davis
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From: Ip-health <ip-health-bounces at lists.keionline.org> on behalf of James Love <james.love at keionline.org>
Sent: Wednesday, March 25, 2020 2:05 PM
To: Ip-health <ip-health at lists.keionline.org>
Subject: Re: [Ip-health] Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation

The wayback machine has snapshots of the CDC "Coronavirus Disease 2019
(COVID-19) Situation Summary" by day, so you can see what was known, when
Gilead filed for Orphan status.


On Wed, Mar 25, 2020 at 1:21 PM James Love <james.love at keionline.org> wrote:

> Gilead folds.  Acknowledges it only made the request in "Early March"..
> well after it was clear the pandemic was not contained.
> https://www.gilead.com/-/media/gilead-corporate/files/pdfs/company-statements/remdesivir-orphan-drug-designation.pdf
> Gilead has submitted a request to the U.S. Food and Drug Administration to
> rescind the orphan drug
> designation it was granted for the investigational antiviral remdesivir
> for the treatment of COVID-19 and
> is waiving all benefits that accompany the designation. Gilead is
> confident that it can maintain an expedited
> timeline in seeking regulatory review of remdesivir, without the orphan
> drug designation. Recent
> engagement with regulatory agencies has demonstrated that submissions and
> review relating to remdesivir
> for the treatment of COVID-19 are being expedited.
> In early March, Gilead sought and was subsequently granted an orphan drug
> designation for the remdesivir
> as a potential treatment for COVID-19. Orphan drug designation is granted
> by the FDA in situations where
> the disease affects fewer than 200,000 patients in the United States.
> Among the benefits of orphan drug designation, this status results in a
> waiver of the requirement to provide
> a pediatric study plan prior to the submission of a New Drug Application –
> a process that can to take up to 210 days to review.
> Gilead recognizes the urgent public health needs posed by the COVID-19
> pandemic. The company is
> working to advance the development of remdesivir as quickly as possible,
> and will provide updates as they
> become available.

James Love.  Knowledge Ecology International
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