Dog Man, I'll go you one better...I'll start from scratch rather than dig anything old up in terms of up coming events to try and inject some cheer.,.,.we kinda need it eh' ?
Ok Here are my thoughts and I will change the format a touch ...this time I'll divvy them up into the Traffic Light System
Green - Most likely going to happen, pretty confident of these upcoming events
Orange - Hmm not so sure on timing, these things will happen...but let's just wait and see before we crack open those little party poppers and drink beer...ok champagne ok ok a whiskey(Drink in moderation).
Red - These things are slated to come but who knows? Good to have them at the back of our mind.. may or certainly may not take place...
Remember, all the below my own thoughts, I could be quite wrong indeed!
Green - Most likely going to happen, pretty confident of these upcoming events.
12 month 008 data
Now originally I always thought this is a bit ho hum. Don't get me wrong...the data is looking pretty snazzy....but in light of 008 56 day and 6 month? I always thought this is just going to be really a check box exercise!
But, I'm wrong...
This is actually going to be more pivotal than even I give credit for and you know I love the science...specially when the science has capacity and propensity to make a difference.
WHY?
Because of a few aspects:
Yes more clinical data, think pain and function but it is so much more than that...
It's SEPARATION, this is the key word. How do the respective cohorts of Active and Placebo perform AGAINST each other?
Are we seeing a noticeable drop off in the placebo cohort AGAIN after the 6 month to the 12 month stage? It will be insightful, maybe we only get a snippet at high level, the granular data could be quite telling.
The same then applies for Rescue Medication and PGIC. Yes both of these data sets are valuable and the agency will give us credit for them. I quietly suspect that its not a linear relationship, the fall off of placebo compared to us, I'm hoping its at least somewhat of an exponential decay....they fall harder and have to go to more rescue medication than the average of our active cohort. Lets wait and see.
Can we see this, as an example in a chart to make it more poignant?
Yes please...
Fig 1 - A good result, linear relationship...Placebo and Active cohorts continue in similar fashion....Scale on y-axis could be Pain...could be degree of Rescue Medication etc
Fig 1 - This is not bad....look at grey lines of separation between cohorts. - Not actual data - illustrative purposes only - do not rely on this.
Fig 2 below, much better, Active on a linear path but placebo on a further decay trajectory?....they were taking rescue meds at around 3 times a week at 6 months, now at 8 months, at 12 months will it further increase up, maybe it is 4 times a week...active might be a little more frequent compared to 6 month but certainly not the spiralling downwards?
Fig 2 - Will se see this? - Not actual data - illustrative purposes only - do not rely on this.
"The twice-weekly iPPS treatment group used rescue medication the least during the first six months of the study (Day 168). Rescue medications could include paracetamol or NSAIDs used by participants to manage pain symptoms. The placebo group reported using rescue medication on an average of 23 days compared to an average of only 5 days in the twice-weekly iPPS group".
I'm putting MPS VI data from our Brazil study here as we know this will come up, it wont be till the end of the year sometime but its on my radar for sure. With some 13 patients or so, this is actually a big study and will be an insightful read out by end of Q4....I want to see how the observations perform also in the youngest cohort. I think back to the amazing animal studies we have see in this area, the actual modification of cartilage is outstanding...I know it, you know it but wait till more of the world knows about it!
Orange - Hmm not so sure on timing, these things will happen...but let's just wait and see...
Well it will come, we just don't know when...MPS Peer review data along with 008 Peer Review Data. This will be very insightful, these reviews always contain a plethora of data and scientific observations. Yes of course we will go through these in great detail, but imagine the waves these things could create out there in not only the scientific community but for the Big Pharma and the odd Bio analysts that gobble this up for dinner (dessert!).
Discussions with the authorities, again I should have this in the Green section as we know these will happen, I'm a touch unsure on the exact timing, its slated for Q4/Q1...there are a few moving parts that need to come together for this to happen. At the end of the day if it is more Jan than Dec...does it really matter? The data they put forward is going to be like a bat outta hell...
What am I saying?
Well let's have a high level peruse:
1) 008 56 day and 6 month data - Pivotal to the extreme (my views)...Sheesh I'm talking multiple Wet Biomarkers, I'm talking STRUCTURAL observations in JUST 6 months of data (this is feint worthy in the Mozz Books)I'm taking immaculate safety profile and I'm saying ALL OF THIS in less than 20 patients in each group?
What?
Yeah let me repeat that...not just ONE bio-chemical biomarker of a prognostic nature...I'm talking at least 5. Then add potentially the structural biomarkers, BMELs, JSW?
2) Now I give you all of the above but at the 2 month time point. Is this not spectacular? (subject to data)...how does the placebo cohort perform compared to us now....if we show data even somewhat like 6 month in aspects...its going to be exemplarily...further separation of pain and function...durability of the drug? This is what we want...
3) have we forgotten about Canine human 3 year equivalent data? Par haven't forgotten...this too will get submitted as part of this amazing data pack. Never been seen before? Mate.
4) MRI's - I can't say enough here...this section in that dossier will be GOLD (spec comment). Well why is it spec? We know that not a few...not most....but ALL patients got some benefit...surely this will now be telling us that the MRI's as a group will also triumph over placebo? Lets see how this pans out. We may not get to see them but as long as the authorities see it...as long as a future Massive Global Pharma see them...I'm happy.
How do I know this? 005, we had a teeny glimpse...we get hints in the announcements to date that what we are seeing is structural...we get posters like my pal Adherent that shows us his own MRIs'. and a number of other HC posters on here that have never gone back to baseline.
This was the data PAR presented after 005. All very good but that's just one image Mozz...
Ok you got me...but I got you, look at the overall mean data of the group then:
PR himself said no patients to date have gone back to BASELINE...he said that before us at the AGM.
That is prolific.
Red - These things are slated to come but who knows?
I put the deals in here....look I think an MPS deal could actually slip into the Orange bucket back up there but I think after all the antics of our market just recently, it pays to be a bit on the conservative side. I think these will happen, we just don't know the timing. Par, I hope these happen, hope you spring these on us like the magic of our drug!
We could be talking OA deal in some part of the world...we could be talking MPS deal...there are a few wild cards we might have randomly in our deck of cards...
Look there is a whole heap of surprises that COULD happen here...we can't forecast how these things could pan out.
Yes we have been a little accustomed to some delays here and there but what a lot forget is that the reason that this has sometimes happened in the past is due to the broadening of the base. We no longer are merely a pain and function drug company.....we have broadened it to...and we are broadening it to...possible DMOAD.
Now that I have stated that I must caveat it by the fact that DMOAD is not a joke...its not a little study we do on the side, we get some positive results and we find ourselves all on the QEII bathing in success....no no no...its hard..it's going to be arduous, we are going to need some proof and at some degree of scale.
What I'm saying to you is that if we get to end of Q1 and we get some info that DMOAD trial is set up but it needs some work, don't come crying to me ....its a long play, there is a lot involved...but mate, we make it through a study like that and I'm going to be fairly happy.
Of course there are faster pathways and other markets we can broach. I gotta be a bit careful saying AA as you-know-who might add you-know-what to the banned images and words list? Pool_Lord, you are looking well today.
Wild cards, there could be others, some I may have forgotten or not covered? This is the thing with us, when you have a few programs going...we just don't know what could strike and when...there are other events that are unknown, think of US coverage...other Countries wanting some action...other data points and papers....maybe even some more patents for indications we weren't aware of.
Keeping us on our toes in trying to imagine what's to come?
(20min delay)