Think this one could have the potetial to be really big... Check out the company info and post any thoughts you have... has massive potential

Up 12% today. Could be a lot higher shortly

Drop 19% - why is that?

profit taking

Stem cell technology (hybrid) in negative light this morning on BBC, see http://news.bbc.co.uk/1/hi/health/6230945.stm.
Should not affect ReNeuron though

It is likely that the BBC 'news' is in mode of "there's no such thing as bad news". Those in the know re SCR appreciate the significant benefits and therefore RENE has a great future. That type of news only serves to make more investors aware and hence quid pro quo.

More negative news for RENE...clinical study put on hold by FDA

ReNeuron Group plc
09 January 2007

Regulatory Update

Guildford, UK, 9 January 2007: ReNeuron Group plc (LSE: RENE) today provides an 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 US Food and Drug Administration (FDA) has orally confirmed that it
has placed the proposed clinical study on hold. A telephone conference call
with the FDA to discuss the application is expected to take place later this
week, following which the Company will make a further announcement.



Michael Hunt, Chief Executive Officer of ReNeuron, said:



'We are encouraged to be able to engage in an immediate dialogue with the FDA
regarding our IND application, now that the initial review process has taken
place. Given the ground-breaking nature of our ReN001 therapy and the lack of
comparable approaches addressing stroke, it is not surprising that the FDA might
wish to raise questions or make comments at this point in the approval process.
We look forward to a constructive dialogue with the FDA and, in the meantime, we
continue with our ongoing preparations for the initial ReN001 clinical study.'

Buying opp? RENE Bid: 36p Offer: 38.5p Change: -7.25

I think this will go down to 25p.

HYLEO
Not exactly 25p. At current 46p think they have a bit further to go

It looks more like it is heading for single figures.

It is already 25p today as I predicted...and I certainly agree with Haystack in his case as RENE has no potential viable product in the short to medium term.
IT IS HEADING FOR 15P next stop. SELL!

interesting reading from other thread:

smokin_jokin - 4 Apr'07 - 09:55 - 3546 of 3547

End of tax year lots of people dumping stock to get under CGT threshold, they will be buying back in next week again though...these should tick up hopefully. Love to buy more at this price, but now fully invested.

News soon.

water30 - 4 Apr'07 - 10:17 - 3547 of 3547

Was a former holder of RENE a few months back. I have bought back in because I believe it is massively undervalued but most importantly, I like the potential here. Will look to add more if the price drops again.

:-) enjoy

More...

TOPINFO - 3 Apr'07 - 15:59 - 3543 of 3547
I wouldnt go that far but its cheap now thats for sure. Remember broker target is 106p at least.!!!

It's not even all-or-nothing.
First we have to overcome the US Authorities, just to start the trial
then we have to wait, hope the trials are positive
and that US Authorities don't put it on Hold again!
and then the Trials have to be positive . . . . and PAID for - that's not cheap!
Then we have to wait for Approval, a commercial deal etc.

Of course by the time we're half-way through the sp will be doubled - but that still means many hurdles before we get there........just overcomming the US-Hold appears to be taxing Execs....I wonder why? . . . . This is nearly 1-year on. . . .

If in the meanwhile they need more Dosh - there will be a Placing; so your investment will be diluted, so anything you paid will have cost, maybe 10% more (effectively)....Grr.

Widow and Orphan status springs to mind! - no not the patients who are delayed treatment by the FDA ( see RNS and sp fall today - Yikes!),
No, - I mean the remaining family who "might" have been spared widowhood, at least for a few more weeks, months, etc.

Of course FDA has a responsibility towards trial patients - but to delay Trials twice smacks of Nimbyism, but that's just a sly view - if they fall any further, I might buy for the "future" - the present can't get much worse - or can it?

Perhaps we should allow more foreigners into Britain provided they take part in Trials - they wouldn't mind, would they?

Attention, Attention....

These boys are shifting, look out

Nice rise yesterday, how far is it likely to go. Current sp of 13.75 mid is mcap of 21million approx. Was 12million 2 days ago.

yeah, I have my stop loss set at 13p at the moment..... I think they could be good to 15p maybe, but time will tell.

The Government had passed a new bill unrestricting the use of certain stem cell techniques

Very surprised that this has not been flagged up in the last few days.
Share price rise has been terrific on the news from America that the FDA has authorised stem cell research to go ahead in human tests, and it has also been ok`d by UK authorities to go ahead with their stroke stem cells in human tests.
They are still talking to the FDA, and if this turns positive then the price at the moment will be extremely cheap.

Alert serviceSite mapSearchHome
Home News & events NewsNews article
ReNeuron gains UK regulatory approval to start ground-breaking clinical trial with stem cell therapy for stroke . 19/01/09
Guildford, UK, 19 January 2009: ReNeuron Group plc (LSE: RENE.L) today announces that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a first-in-man clinical trial for the treatment of patients who have been left disabled by an ischaemic stroke, the most common form of the condition. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

In this ground-breaking Phase I trial, the first of its kind using expanded neural stem cells, stroke patients will be treated with ReNeuron's ReN001 stem cell therapy at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. The Principal Investigator for the trial is Dr. Keith Muir, Senior Lecturer in Neurology at the University of Glasgow. MHRA approval for the trial has been given subject to provision of data both from an ongoing pre-clinical study and from the long term follow-up of trial participants. Following successful completion of the ethics approval process which is currently underway for the trial, patient recruitment is expected to commence in the second quarter of this year.

The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial. The ReN001 cells will be administered by direct injection into the affected region of the brain in a straightforward surgical procedure. Importantly, the nature of the procedure and the characteristics of the ReN001 cells mean that the patients will not require immunosuppression following treatment, thus eliminating the safety risks typically associated with immunosuppression regimens. Patients in the trial will be monitored for one year, with longer term follow-up procedures in place thereafter.

Dr. Keith Muir said:

"Stem cell treatment offers the potential to repair brain tissue lost as a result of stroke. We are very excited at the opportunity to undertake this, the first clinical trial involving neural stem cell therapy in stroke. At this stage, we are primarily seeking to establish the safety and feasibility of this form of treatment, and if successful, we hope that it will lead on to larger studies looking at the effects of the treatment on patient recovery".


Michael Hunt, Chief Executive Officer of ReNeuron, said:

"This regulatory approval marks the first step in the process of testing the safety and potency of our lead ReN001 stroke therapy at a clinical level. It is the most important milestone in ReNeuron's history thus far and also represents a significant development in the wider field as regards the translation of exciting stem cell science into clinical stage therapies. In many ways, ReNeuron has set the regulatory pathway in the UK for cell therapy trials of this type, and we are delighted to have been given the opportunity to move ReN001 into its clinical phase on home territory in the UK"


Enquiries:

ReNeuron