Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

WAY FORWARD FOR AVIPTADIL???

Accelerated assessment reduces the timeframe for the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing-authorisation application. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation.

Evaluating a marketing-authorisation application under the centralised procedure can take up to 210 days, not counting clock stops when applicants have to provide additional information. On request, the CHMP can reduce the timeframe to 150 days if the applicant provides sufficient justification for an accelerated assessment.

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/accelerated-assessment

DOES RLFTF HAVE ENOUGH TIME TO REALIZE/MAXIMIZE THE PROMISES OF AVIPTADIL BEFORE THE PATENT EXPIRES???

2006-03-07…Application filed by MondoBiotech AG

2008-07-03…Publication of US20080161237A1

2012-05-15…Publication of US8178489B2

2012-05-15…Application granted
Status

Active - Reinstated

2029-07-03…Adjusted expiration

https://patents.google.com/patent/US8178489B2/en

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016.

In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case (Takeda’s Ninlaro (ixazomib) for multiple myeloma), FDA approved the treatment and EMA initially did not, but later did.

“Overall, taking account of the resubmitted and reexamined applications, the EMA and the FDA had final discordant marketing authorization decisions for two drugs: corifollitropin alfa and ataluren,” the study notes, as both were approved by EMA and not FDA. ~ RAPS