Those statistics of a drug successes is something that is often quoted as a bit of a ‘reality check’ which is fine and needs to be taken into consideration.. but these blanket statistics do not take into account or drill into the finer points
Of the 30% that do make it from PII - PIII what sets those successes apart from the 70% that don’t… what does 100% of the 30% have in common or show earlier on that the others don’t - what is the X factor - is there any tell-tail signs for the winners or are all drugs created equal and at equal stages of development have exactly the same chance of progressing as the next drug candidate no matter what?! Blanket statistics say all are equal but in reality they are not as not all drugs are of the same concept or function obviously otherwise there wouldn’t be passes and failures lol How does a farfetched or unproven concept weigh up with a proven one? or a validated one? Is there such thing as early proof-of-value…. or is it all just a lottery?!!
It takes understanding, time, research and a little knowhow to pick the more probable from the unlikely. The big pharmas for example; what makes them go for a particular drug at early stages over others? What makes the international pharma in negotiations with ANP think that ATL1103 will be one of the 30% that do make it through and why did they approach ANP?
Truthfully the answers to these riddles are in the research. With Antisense Gen2 we have the ability to determine long-term results in man from as early as preclinical results with primates as proven with several from the isis platform including mipomersen… primate liver and human in the case of coding are much of a muchness so we have a good idea already how 1103 will perform in late stage human trials. So with ATL1103 we have a good safety profile, pharmacokinetics, bio markers, reduction of Igf-1 and during pI reduction already ahead at intended doses…and to tie all in together the operating approach being used to generate results is a simple function.
What is validation really - is it approval by the FDA or EMA… is it passing PIII trials?
A lot of the larger pharmas and articles these days quote that the one true form of validation is a drug/device or ‘idea’ that generates a profit or ongoing revenue. You can have the most effective and safe drug in the world but if there is no market for it, or no profitable why to validate it then is it really a validated drug by any means other than working really well?
To this extent isis has an already validated platform as they are already reaping the upfront payments from very early stages as recently shown with gsk they were willing to jump in the deep end as early as preclinical with Antisense Gen2. These tie-in agreements that include huge upfront payments and milestones are something that very few bios are able to pull off with the large pharmas so as far as isis are concerned they’re already generating a massive revenue and to an extent already validating the antisense concept.
There are an elite few or around 25% amongst the pipeline which have the factors to obtain staggering figures from earlier stages and this has been cover many times on these message boards and is plain as day with a bit of research. 1103 is one of the 25% that can pull the figure that Mipomersen did post PII and given the likely increase in JV value 1103 will reap once mipo is approval I personally think that 1103 could dwarf mipos upfront tie-down value of $375 million upfront and 2 billion in milestones and royalties… With ATL1103 ANP have gained the extended insight of movement on bio markers during PI that are key to our end-efficacy.. these same markers were as quoted by the prof. as reduced further than first expected given the level of dose given! This insight for how PII will come off is pretty extensive and reduces risk for safety…. as well as the drug type which reduces risk of all trials from PI-PIII… over 20 years of research there is just so much known about these drugs at this stage of th game that the FDA just love it from an approval perspective.
The first systemically administered antisense Generation 2 oligodeoxynucleotide drug gaining approval is not something that just helps further drugs from the same platform obtain approval after PIII trials… it is more so a validation of the method of technology being used which obviously can account for drugs as early as pre-clinical stages………therefore increasing the overall value of the breed!
One things is for sure… it is the long term holders that will do best out of ANP and imo that means years not months… those on here calling tic by tic movements are watching things far too close or have far too much on the line or too much time on their hands lol.
Fair enough I also get excited by macro-developments with ANP and it is sometimes hard to contain excitement but at this stage it appears the right things are happening in the trading of ANP and in the past 6 months things have unravelled at a natural pace which is not just going to be undone or made by any one trading day or buy/sell parcel size at any particular moment in time lol
Just some thoughts!
Good Luck All!
ANP Price at posting:
19.0¢ Sentiment: LT Buy Disclosure: Held
