Yes good question. We recently took a stab at this but it's a good chance to add some material.
The answer as with a lot of things, is not straight forward. yeah the water gets a bit muddied.
Why? Well because there is a number of ways to slice and dice the data.
Are you talking recently? Are you talking over a greater length of time? Are you wanting just a general answer across all indications or do you want to narrow it down to immunology/inflammatory concerns? As JTL points out, a little above this post, our answer might vary from country to country or patient profile.
Now I know I'm being a bit granular and you most likely just want a general answer. In that case Ox and Beaza have it covered.
I would also say it seems to be around that 65% mark... a bit of other data to help answer:
Across any given modality:
The way this works is that it is cumulative...so if we are sitting here today having passed our P2 already ...we in theory have a 58.1% chance of getting through the P3 (on the proviso that we are allowed to start our P3 of course). Once that is out of the way successfully then we have an 85.3% chance of getting to approval status. So in other words cumulatively, we have a 58.1% x 85.3% = 49% chance of making it once IND is open to approval.
Now that above statement is so full of caveats that it aint funny.
Some examples of the warnings:
1) This is so averaging its bordering on insanity, each case has its own idiosyncrasies 2) This data is from a period 2006 to 2015. 3) It's broad when you include all diseases and indications
Another comparative is where a drug is not a new molecular entity (NME). In our case we are not a new molecular entity. Why then do we have to go through a trial if we aren't new? Because the new route of administration has different potential effects of the drug thus the repurposing pathway is applicable.
We see a bump up in the statistical averages when looking at NME. This is an example of what I mean.
Using the above formula, 74% x 90% is a much better 66.6% chance of success from P3 to Sales (Approval).
As I said above, don't read too much into this, they are just averages and across many different types of areas. Each case will have its own merits and the assessment will be based on what we submit, how our drug performs, what are the side effects, what are the adverse effects and how serious they are.
To sway the pendulum a little more our way, a few points that I was happy with to get us to this stage:
Our trial design was created with input from some real experts in the field. Not just any field, our OA field specifically. Some of the team members have been involved with MULTIPLE IND submissions, this derisks our submission substantively.
Our trial wasn't just a simple one heat trial...we have multiple prongs to address multiple advantages all that the same time....I will post more on this later to give you a example of the complexities involved and the issues they solve...the benefits will be tremendous and the average shareholder in my humble opinion are aware of very little of these merits.
Our P2 design is very similar to our P3. This saved an enormous amount of work and potential unnecessary broadening of scope.
We also didn't have to have a third arm (huh!?) I mean we didn't have to compare ourselves to the current std of care, such as Tramadol.
Many other factors will come into play in the eventual determination of whether we get the ultimate ability to prescribe our drug to the public... Did we pass our Primary Endpoint? Did we pass our Secondary endpoints? Are we safe? What other triggers and safety issues are there? How indeed do we compare to placebo. Let me tell you, if placebo is better than us there will be real pressure on us in terms of us getting a pass. I don't need to remind you just how strong placebo can be particularly when there is higher levels of pain involved.
This (placebo effect) is the main reason why we may need to keep advertising of the merits of iPPS and such beaut stories to a low-down of sorts. Not so much in HC, more so out there in the media and official advertising channels....at least until these trials are recruited and are steadily progressing. (My views)
These are the questions I'm coming up without researching too deeply. I just know there will be a stack more... I have a good mate whom I will soundboard off to get many more questions...we'll tackle these and many other posts as we get over the P3 opening hurdle.
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