As most of us already know that the preliminary results of a pivotal European Phase III trial of the BTG's greatest star VARISOLVE were positive.

- Overall response rate in patients (435 patients) treated with VARISOLVE was 83.4%, in line with expectations.
- Established that VARISOLVE is similar in efficacy to conventional treatments (sclerotherapy or surgery) in the treatment of moderate to severe varicose veins.
- The winning factor is that both physicians and patients would welcome this rapid, virtually painless, treatment for varicose veins.

But, the Varisolve US Phase II safety study has been put on clinical hold by FDA, continue to worry investors for about a month now since its announcement. Consequently shares oversold till today. This could be long enough and is an investment opportunity worth monitoring. Any spark of hope could easily double the share price. Base on the assumption that Varisolve may not survive the trails despite additional costs and efforts to do additional tests to accumulate enough proves and statistics or to improve their procedures, which is unlikely although sources suggest that the clinical Hold is more likely to cause a delay of 1-2 years to its commercialisation date, the net current asset value of the company alone is estimated to be around 190 – 250 (consensus from various analyst), excluding any contribution from Varisolve US and Europe. Note that BTG total revenues increased by 35% to 19.1 million (2002: 14.2 million). Investors will bet on the company’s ability to generate enough cash to carry Varisolve through till its commercialisation, which is estimated to be 2005/6/7 in EU and 2007/8/9 US. With institutional investments from Deutsche Bank AG (More than 11%), Amvescap PLC (More than 26%), Bank of New York Europe Limited and many more…, the risk may still remain significant, but definitely one to keep close to your screen. Remember that they have many more high potential projects on parallel development. Opportunity like this don't come often.

Investors are expecting BTG to clarified their strategy and plan to overcome their challenges associated with Varisolve by early 2004. The next important date will be in early February 2004 which may be an opportunity for them to inspire some confidence (2nd Annual BioPartnering North America).

My opinion : Now is the time to get in!!!

Maybe we have a situation where some good news will happen well before anything Bad. Punters would do well to note that at its peak this share was 18 - and even if you remove the peak that leaves some support at nearly 10 - and this was assuming Varisolve would happen.
Well, now it may well! Whenever the Co. reports, a review by the FDA (in US) is bound to cause some excitement here. If it really does get approval, expect a severe case of lunacy! People will be elbowing their way to the phone to get to their broker, let alone worry about the sp. - Now, provided the shares are still below (let's say 5), then you are still better-off than in those distant days when 10 was nearer the norm.
Only time will tell, if Varisolve takes off and profits will flow - but they are not going to be massive - but if the World takes to Varisolve rather than a rival (oops did I say...?) then profits for Varisolve should represent good value at 4-5 if earlier valuations were nearly correct.
Anything near 10 is probably "too high" (until figures are known, etc) so I'd sell at 10 - but will I have the nerve to stay the course to those levels?
Time will tell, but Volume is Up - so someone knows something. (or not?)
Regards as a holder.

Really good News today - FDA go-Ahead.

SP hits 2.25 and falls back on profit taking just a tad.

Looks like those who held-back waiting for news had better bite the bullet.
Yippee and their agm is quite soon.............good news all round.

Friday July 15, 03:40 PM

Varisolve trials given FDA go-ahead

The FDA has given the green light to Provensis, a subsidiary of UK company BTG (LSE: BGC.L - news) , to resume phase II US clinical trials of Varisolve, a non-invasive treatment for varicose veins.

The FDA has given the green light to Provensis, a subsidiary of UK company BTG, to resume phase II US clinical trials of Varisolve, a non-invasive treatment for varicose veins.

The FDA intervened in 2003 to stop trials of Varisolve amid fears that the treatment could increase the risk of embolism in patients.


In March 2005, Provensis submitted data from a one-year program of preclinical studies aimed at enabling resumption of Varisolve's US development, together with the protocol for a proposed phase II clinical study. The FDA requested amendments to the protocol, which were submitted in May 2005. Following review of the amended submission, the FDA has lifted the hold on conducting clinical trials with Varisolve in the US and approved the phase II study protocol.

Louise Makin, CEO of BTG, commented: "We are very pleased that the US clinical development of Varisolve can resume. Now that the pathway for further regulatory development in the US is clear, we look forward to progressing discussions to secure a global development and commercialization partner for Varisolve."

A small development which might have contributed to today's strength and volumes:

Genzyme/Schering Campath Phase II trial update

There's a bit about Campath in the following BTG pdf (page 4):

BTG May 2005 update - see Campath piece

The above Campath news is also released on the UK exchange after midday Monday (today) and causes a 15p spike despite it being public knowledge on Friday in the US.

Campath RNS

Interims due 10th November.

5 Oct22005
Feeling pretty confident in BTG as they say all is "steady as she goes" - they have settled some Patent disputes: the hip-joint issue has resulted in a licensing deal with "Zimmer frame" and we cqn expect a regular royalty payment (as well as a 1-off payment for infringing). The web-click issues looks to be gaining legal strength, although the likes of Y****o are yet to make a move. There is no news on Varisolve, but we don't expect any, do we?
These cash deals on their Patents look like good funding, so we may find investors don't need to be asked again. (hope-so)
The sp has risen about 2x (ie 100%) from recent steady-state just under 1 and those that bought-in then will be sitting on a possible turn (as I do) so it's time to ask:
"Is this stock getting better?"
Personally I think (market moves excepted) there is much* further to go - so expect a sp over 3 before this time next year. That's not too long to wait, is it. If anyone can suggest another stock that's this good, let me know and I may split my risk - it is a bad thing to be very much into one stock, but I think this one has the best chance and all the Stockmarket is a risk. Maybe the likes of Lloyds is safer, and has the benefit of a decent yield. If there is any takeover speculation then that sp will rise another 1 I guess, but that's only 25% whereas another 1 on BTG is 50% and I think BTG is likely to win through before LLoyds is taken-over.
/
That's all folks.....but let me know of alternatives, this good.

* I have to add caution the much more is dependent upon Varisolve and FDA approval......we have to hope this happens as there is little more that can be done - for my money that treatment is a winner and I can see it commanding a premium price, . . . . . . . I just hope BTG realises the potential ........and doesn't sell it short, byalways retaining the right to marrket it itself ...if revenues falter...etc.

Well! recent (quick) fall from over 2 has caused some small selling - many small sales this week as the sp fell towards 1.70 - yet Tuesday (today) I see 4x 20k-ish Buys - all together. It may be random chance, but it looks like One buyer to me.....FWIW.....and 80k is serious money in anyone's pocket.
/
I just don't know....sometimes I feel Management is keeping all the Good News to themselves......but I suspect that there is NO good news....... and they continue to move away from technology towards Bio/Pharma.
/
I'm holding on for now, but it sure looks a difficult call; even with that 80k making the sp movement today about "evens" - is there some News about to surface?
/
A-A-Arggggggggggh.

I just don't get why so many small sales have gone through this week - it's after the tax-year deadline - so could this be small holders in one of their subsidary businesses? We'll just have to wait.
Any views? - even though this isn't a popular share these days.......Anyone amongst the Sellers say "why"?

I think this share has lost its gloss (due to the Varisolve debacle) and although the restarting the sp has only reached a fundamental fair-value (I still hold).
However, I see BTG isn't focussed ONLY on Varisolve, they have manged to move Market-eyes from the one product to the cash position and income, sale of patents etc.
This is a wise move and means that any shocks in the future should have less impact. I can't say I'm over the moon about the delay in Varisolve, but guess we just have to accept it as a "maybe-later" aid to riches.
I am tempted to top-slice having taken a gamble on BGC at 93p, but I expect the results, later in May06, will provide some strength and then I'll review the position. Because of earlier purchases my av. is 2+........and this crashed in the dot-com fall........so, quite lucky, really.

[[Oil-stocks are high-enough IMHO and a sudden shock could be bad-news - such as a Europe-wide ban on cheap flights.
It is well-time that the masses were prevented from poluting the air. This might help preserve UK holiday resort jobs as a bonus whilst staying green. We do need to sort-out mass transport, the likes of rail and integrated bus transport, so folks can be mobile without a car.
Only long journeys to cities are really cost-effective by rail - it needs to be changed, IMHO.]]

The Market doesn't like this shall-we shan't we situation with Varisolve and some even wonder if it will be a profitable exercise.
However, much of the money is already spent - so that's an end to it...and this new set of trials is a pain, but perhaps I just didn't understand "where" the trials were....getting aproval is a route to the loot...and with BTG havoing enough money I'm surprised they even considered having a partner.......to share the profits....for a miserable share in the trials (rumoured to cost 5 million USD) - - So unless BTG has something better to spend its 50/60 million on - - - better put it to good use in the strong hope of a return. The when it has aproval, sell it to the US for whatever the Market will stand - probably double what's currently on offer.(for varicose veins).....it's a popular market although hardly life-threatenung; it has a large-number of patients each year.
/
However, all this rides on the truth being there is a huge $ market (and we get approval)...so fingers crossed - the falls have been a bit worrying, but not so much we have to act....something about being invested ...is better than NOT being invested?

I am wondering whether to top-up, sell, or maybe just hold and wait. Dunno......anyone?

Well it may be I held too long, this week, I've just sold my entire ISA holding (in BTG) as I can't afford to watch a profit dry up. The war in Iraq and the new war in Lebanon just don't look good for financial markets.
Varisolve is some way off so I'm hoping the market will be less interested in BTG as a result....it is unfortunate that investors focus on the one Big product - but that's more-or-less what I'm focussed on so it's the same.
I may buy-in if the story improves.

Ah, what to do?
BTG sp has gone off like a rocket just after Dirs smeared themselves with Options.
Well, the fact is that there can't be any good news round the corner (ie already known or anticipated by Dirs)- otherwise they'd have to say and their Option-pricing would increase accordingly......the sp rise beforehand was due IMHO to MM's knowing the Dirs were about to buy... and buying at any price.
However, the Market is selling BGC stock - almost every day we see records of Trades that would suggest there are plenty of Sellers at current prices - yet the MM's continue to push up prices.
Well, for the time-being I'm not convinced that my ISA should be stuffed with this stock - I fear there is yet to be a correction in advance of any news (please!) on a Partner for Vs......why is no-one interested (ie US-Pharma Distributors), I wonder?

Good interims today
next year could be sweet

Good results today from European phase III Varisolve trial.
This may help with partnering negotiations, and with more news from BTG's R&D pipeline on the horizon the next few months could spark the SP.

Late Feb 2007
- Seems BTG's prostate product is up to expectations - - yet the sp is not recognising this - - - probably we are too concerned with Varisolve which is in "Quiet season" this year also.....

-Still, it looks like the BTG-pipeline is alive and well.
Early-days for this treatment, but encouraging that Management have turned this company into a discovery and exploiation co. (the discovery bit being relatively easy.). Vs is "no-news" which is to be expected....
Ah well, wait a bit longer - - -