Member Info for daringinvestor

hawkhead has a point.

I have to admit, hawkhead's comment "Will break 50p today. But if it doesn't it might go down even. Don't rule out staying the same either" did make me laugh out loud.

Some people believe in charts, some don't. Each to their own

Good Morning
What a pleasant atmosphere we have this morning

hahahaah It's spiderman again...

Thomas - he's asking for advice from you and it seems like it's another bitter and twisted individual.

I think the advice you should give him is, "if phase 3 are positive the share price will be 4567892843654.00 and if it's negative it'll be 0.0000000000001.

That should give Spiderman enough of a range to work with.

kdonkey - The Erectile Function score is a series of questions and I think the maximum score you can get is 30. For example, one of the questions is "are you always able to maintain an erection throughout intercourse"... then the answers are "yes always".. that may give you 5 points. The next answer may be "yes mostly".. that would give 4 points etc etc... one answer may be "never".. that would give 0 points...
According to the internation guidelines for Erectile function scoring, if someone got a total score between 17 and 25 out of a maximum possible score of 30, they would be categorised as having mild Erectile Dysfunction.
Hope this clarifies!

Hi Tommy
Before phase 2 was carried out, the only side effect profiles that were available were the one's that were done in a clinical setting. As you know, the side effect profiles observed in a clinical setting is far higher than in "home use". In fact the low side effect profile that was recorded in phase 2 "home use" actually surprised everyone.
Given that they only had the clinical side effect profiles to go with, they chose only the 0.2% dose. Futura Medical were advised against using a higher dose due to the side effect profile seen in a clinical setting.
Hindsight is a wonderful thing as they say!
The other reason was to save on costs for the trial

MED gel showed an improvement over Placebo when it came to the 5 minute mark.

What the report does not go into detail about is whether it was the mild group of patients that showed this improvement. If only we had more details..however when looking at the other data I suspect it was the mild group of patients that showed the slight improved onset of action over placebo.
As we increase the dose, the dose should be able to break away from Placebo further for the mild group and hopefully the 0.6% dose does the same with the moderate group of patients.
However the proof will be in the results as they say... The PK study results certainly support the theory but as we all know, it's not all done and dusted until we see the results.
GLA

Any discussion points on this or anything not covered?

Let's now go back to the question of onset of action (start of erection). Bear with me , hopefully you get your head round this.
There was no real difference between placebo and MED at 10 and 20 minutes when it came to noticing start of erection. However when it came to the 5 minute mark, the MED gel showed a slight improvement over the MED gel. There are lots of reasons why this may have happened, however I want to explain why I think this will change for phase 3.
The 0.2% dose achieves it's max concentration in blood in 12 minutes.. Let's call this x mg/ml. The 0.4% dose that is being used in the trials achieves the concentration of xmg/ml in 4 to 5 minutes and eventually achieves 2 times xmg/ml in 12 minutes. The 0.6% dose achieves xmg/ml in 2 to 4 minutes and achieves 3 times xmg/ml in 12 minutes. In other words, the likelihood of MED gel breaking away from placebo when it comes to the onset of action claim for phase 3 increases as the dose is increased.

The other thing is as the concentration of MED gel is increased, a higher concentration stays in the blood for longer. This is important when it comes to duration of sex. I think we will see a positive impact when it comes to this and no doubt the potential commercial partners will be looking at this as the duration is important too. For example if the 0.2% dose had a residual concentration in the blood of 50 mg/ml after 20 minutes, the 0.6% dose may have the same concentration of 50 mg/ml at 30 minutes…

For me it is important for phase 3 to show an even greater improvement in the EF score when using the higher doses not only in the mild but the moderates too. Not too concerned with the severe cases, however even the severe cases may find they prefer to use it for the secondary claims (i.e. increasing sexual desire and orgasmic function etc etc)

Just as an introduction, the International index of the Erectile Function (EF) questionnaire has a series of questions. Depending on your answers, you are given a certain number of points. These can be divided into the following categories
1. Erectile Function. (these questions determine the score for EF and determine the primary end point)
2. Orgasmic function (this makes up the secondary questionnaire which determines the secondary end point)
3. Sexual Desire (As per point 2)
4. Intercourse Satisfaction (as above)
5. Overall Satisfaction (as above)

The mild group had a EF score (item 1) of 17 to 25. The moderates had a score of 11 to 16. The severes a score of 10 or less. The mild and mild to moderates a score between 11 to 25.

Let's first discuss the primary end point. If you look at the study, it was heavily geared towards patients with mild ED, with a mean EF score of 20 from the UK and 22.4 in Poland. The experiment which used the lowest dose of 0.2% achieved a P value of less than 0.0001 on this group of patients. In other words there is less than 1 in ten thousand chance that it was by luck. It's possible that that the dose worked on the moderate patients that had an EF score at the upper end of the bracket for moderates (11-16), however I would not deem it a success on the moderates and severes and I would not pay too much attention on the mild and mild to moderate group. I would keep it simple as mild, moderates and severes.
So in summary there is less than 1 in ten thousand chance that it was by luck that it worked on the milds. The moderate cases it did not work and the severe cases it did not work (for the 0.2% dose)

Let's discuss the secondary end points now. The 0.2% dose of the MED gel performed across all patient groups when asked about whether it increased their sexual desire including the severe cases! When asked about intercourse satisfaction, all groups showed improvement apart from the severe cases. When asked about orgasmic function, all showed improvements. In summary, when it came to the secondary questionnaire which is mainly used for commercial claims, it performed exceptionally well.

The only other thing I would add to what Hawkhead has stated is the condom market is totally different to the erectile dysfunction market when it comes to global players.

The condom market is, lets face it dominated by two major brands.

The Erectile Dysfunction market on the other hand has many many different players especially with the rise of Generic Viagra and Cialis.

However Hawkhead makes some good points about past mistakes should be learnt from. I am of the opinion we should NOT attempt another licensing deal. The rights to MED should just be sold

I'll summarise the paper myself and post on here in a couple of days perhaps.

I'm abroad right now in the middle of an oil field so will need to find the time.

I think it will be good for everyone and I'll keep it balanced. Post both the positives and not so positives and detail what the company is doing to overcome them

Look, we're all here for helping, however consider this
Spiderman asked this question the first time and got a response
Spiderman then asked the same question and got another detailed response from a couple of posters asking him to go and read the paper in full and interviews and join the dots.. There is A LOT of information in the paper

Spiderman then asks the same question. Why invest in something that you don't understand? or don't want to understand perhaps.

Hawkhead is chatting $hite
It clearly shows his level of understanding if he is comparing IMM to FUM when there are so many differences between them, including but not limited to
1. The condition that was being treated
2. The previous history of comparing efficacy with a placebo
3. The phase of trial
4. The sample size (which determines to an extent the impact of the placebo response rate)

Absolutely laughable

Spiderman should go back to his day job (saving the city from crime)..

I've tried to point him in the right direction.. If he can't understand it after reading the paper, then I'm afraid he should not really invest.

To all existing and potential new investors...Please read the paper from phase 2 that was published.
Do not believe the crap and misleading comments being posted by people who don't have the brains to fully understand that paper.
I admit, it is not the easiest to follow and understand, but if you invest your time trying to understand it, you'll be better placed to make an informed decision.

GLA

The value inflection point will be when they make their first profit.

Forecasts are just that …"forecasts".. They can be met, exceeded or missed.

Hopefully the forecasts will be exceeded.
Until we make a profit, I'm afraid it'll tread water..
The management need to carry on doing what they are doing (and they are doing an excellent job in my opinion) and the value will be realised.
GLA

I think people should be free to discuss their view points as long as it is done in a professional manner.

No one should stop anyone from making their point of view.

We all need a balanced view and a discussion is actually healthy for all shareholders.

Exactly Azurite... I just can't understand all the arguing..
The share price is what it is... Deliver on phase 3 and it'll be all well and good.

Spiderman - It's worth reading the paper that I pointed you to last time. The paper goes into great detail about Placebo effect etc and the questionnaire that was used as part of phase 2.
I will try to give some brief points below but the paper goes into much more detail.
1. The MED gel was clinically superior and met it's primary end point for mild and mild to moderate patient group.
2. The number of men in the above group that reported the MED gel increased the firmness of their ***** over and above the placebo was statistically relevant
3. The number of men that reported the gel increased "their sexual desire" was also statistically significant, way above the placebo.

4. The number of men that were satisfied was statiscally significant (over the placebo)

The placebo effect is not to do with the firmness or erection. It is more to do with the "onset" of erection. Although this does not matter in the over-all scheme, (they can change the claim to a 5 minute onset of use ), FUM are hoping that the increased doses will help break away from the Placebo when it comes to the "onset of use" claim too.

The higher strength doses should help us gain an increased amount of improvement over the Placebo when calculating the penile score before and after treatment.

The reason the share price fell is this is the downside of having only one institutional investor, who at the end of the day are there to make money at the best possible terms and FUM found it'self in a vulnerable position.

Lessons need to be learnt and I'm sure they have. This time round, with the phase 3 data and increasing coverage and with the PR campaign in full swing, FUM should be in a much better position..The fact that we have not had serious adverse effects (so far) should be a big plus, and all of us are hoping the increased dose strength really helps us break out. The 0.2% dose was really the bare minimum so looking forwards to the other doses especially when we know as we double or triple the dose, we get the same amount of increase in the blood.

GLA

it could rapidly turn into a wet dream.....