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Biotech / Medical : Stem Cell Research
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From: nigel bates1/12/2007 7:26:47 AM
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Guildford, UK, 12 January 2007: ReNeuron Group plc (LSE: RENE) today provides a
further update regarding its recently filed Investigational New Drug (IND)
application to commence a Phase I clinical study for its ReN001 stem cell
therapy for stroke.

The Company announced on 9 January that the US Food and Drug Administration
(FDA) had placed the proposed clinical study for ReN001 on hold. A telephone
conference call with the FDA to discuss the application has subsequently taken
place, during which the FDA outlined its questions and requests for further
information regarding the IND application. The Company expects the FDA to
confirm these comments in writing within the next few days.

The points raised during the initial teleconference were largely as expected and
are readily addressable. Indeed, the Company believes that the additional
pre-clinical studies it is currently undertaking may answer the main points
raised by the FDA during the call. It is noteworthy that no substantial issues
were raised during the call that had not been covered in previous dialogue with
the FDA.

Michael Hunt, Chief Executive Officer of ReNeuron, said:

'We appreciate the diligence with which the FDA are reviewing our IND
application for ReN001, and for providing the Company with the opportunity to
engage in dialogue at this early stage in the approval process. We will be
continuing our dialogue with the FDA as we work towards providing the additional
information required. On this basis, we are confident that approval to commence
human clinical studies with ReN001 will be granted.'...
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