Avid Bioservices Inc (CDMO)

[biopharm]

European Medicines Agency : April 23-25 and Belgium roots are now looking to be playing a key role here as "Class Waiver" is on the table for discussion for Bavituximab --- page 4/7

http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2014/04/WC500165521.pdf

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Also would like to point out that "Bavituximab" was up for discussion back on the March 19-21 EMA schedule.

http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2014/03/WC500163265.pdf
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... just coming back to this, a little more info on why Peregrine is seeking a waiver. The most important thing is this shows Peregrine is active within the Regulatory front in Europe.

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of a medicine for children. Pharmaceutical companies submit proposals for PIPs to the European Medicines Agency's Paediatric Committee (PDCO). This Committee is responsible for agreeing or refusing the plan.

As some diseases do not affect children (for example Parkinson's disease), the development of medicines for these diseases should not be performed in children. In these cases, a PIP is not required and it will be waived. For more information on the classes of diseases subject to waivers, see class waivers.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000293.jsp

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NAVIGATING EUROPEAN REQUIREMENTS

This is changing: both the European Medicines Agency (EMA)
and the U.S. Food and Drug Administration (FDA) now require
paediatric plans as part of the development and approval process for new drugs and new indications.

Since an approved PIP is required before review of a Marketing
Authorisation Application (MAA) can begin, drug developers in Europe must start thinking about their paediatric plan much earlier.

... so looks like the "class waiver" is running its course before a MAA can begin.

Drug developers should also be aware that the EMA and FDA have monthly teleconferences. These meetings are not public, but it bears remembering that the agencies do talk and will compare notes regarding what a drug maker has told each.

.... would like to be on that conference call when Bavituximab comes up...

http://www.incresearch.com/news/InTheNews/PHARMACEUTICAL_PHYSICIAN_March2012_Sietsema-Klaus_article.pdf