run coming?, page-84

Still a long way for the share price to go up in my opinion.

We have lots of near term news.

First trial enrollment completion.

Then the trial results themselves. Trial results are never a given, but we have many reasons for optimism. Past results and the current trial data we have all points to positivity.

Those snippets of current data we have suggests a very good result in my opinion. The power of a good result cannot be underestimated imho. Because:

* It means it is easier for EU and other territories approval.

* The product will be more to attractive to doctors and health practitioners.

* It means partners will be more interested in the product, and a better deal can be negotiated.

* It reduces the likelihood of failure for the phase 3 trial, required for US approval.

* It shows that success in other indications is more likely.

The next news would then be I guess about partnering negotiations or signing. The application for use in the EU and other territories and news about other indications.

Given all the above, I would suggest a current mkt cap of over $100m is reasonable. Again, there is trial failure risk, but I deem that to be unlikely.

I did write an email to Rosalind Wilson and I received a reply today. My email is a bit long winded, but I will post it in full and her reply. I assume that she won't mind me posting her reply. It appears she reads Hotcopper, so be warned!!!

....
My email:

Dear Dr Wilson,

My name is (deleted), and I am a long term shareholder in Factor Therapeutics.

I would first like to say thank you for all the great work that you and your team have done.

I have a question or two about the phase 2 clinical trial that we are nearing completion of.

I notice that in the benchmark study being quoted 41% patients fully healed. In our trial it's currently 53%.

If we assume in our study that the placebo's third is similar to the benchmark study, then the two thirds on our drug have a full healing rate of close to 60%.

60% compared to 41% is nearly a 50% improvement over the benchmark, which is a hugely statistically significant benefit.

Then there's the 50% healing data showing a possible 300% improvement, again assuming that the placebo's result is similar to that of the benchmark study.

But in our trial there is a two weeks screening period to weed out those who will easily heal on standard treatment, which was not the case with the benchmark study, so our placebo is likely to perform poorer than the benchmark study.

We only need to show a 10% improvement over the placebo for trial success, but we might be looking at a 50% or 100% improvement or more.

Now this is a clinical trial and the data is blind, so one can never be too sure and there is always risk, but my question is are my observations correct? Do you have a similar view or am I missing something?

Any help would be appreciated.

With kind regards,
(deleted)

ps. I use firefox to view the internet, and the factor website comes up with an unsafe website message from firefox, which is most unusual.

...
Her reply:
Good morning (deleted)

Apologies for not responding yesterday; we’ve been having internet issues at the office. Thanks also for letting me know about the website – there’s an expired security certificate that is being sorted out at the moment. Hopefully it will be resolved today.

The study is looking promising and we’re really pleased with the way the data quality has evolved over time. I know the recruitment has been slower than was initially estimated and we’re very appreciative of everyone’s patience – not long to go now.

In regard to your observations, I would tend to agree but, as you rightly point out, we need to be cautious to not over-interpret the dataset while the study remains blinded. Having said that, the maths is fairly straightforward – the curve from VF00102 is the sum of the three curves that we’ll see when the analysis is done later in the year, with one curve for placebo and the other two for VF001.

The VenUS III benchmark is our best estimate of how a group of patients respond when they are receiving well-managed, consistent standard treatment – which is what we are aiming for with the group in VF00102 receiving placebo. Again, making “cross-trial” comparisons is something one has to be very cautious about – the furthest one ought to go is to look at it in qualitative terms.

My interpretation of our blinded dataset is that we are seeing a good overall healing response, with rapid reduction in the wound size in the first four weeks and the number of patients who are healing fully. This gives us confidence that, if our treatment does indeed “work”, then our study dataset is robust enough to pick that up.

I hope this helps and please feel free to follow up with any other question you may have – I have been following the discussion on Hot Copper!

Kind regards

Ros

Dr Rosalind WIlson
Chief Executive Officer