So the biggest caveat and one that I must start off with, is that this is ALL complete speculation on my behalf. It's very possible that I will have at least some part of this incorrect, though I believe it serves as a rough guide, mainly for the new guys on here that don't really know all that much about us.
It's a bit like one of those volunteer guides that aren't getting paid (I'm not being paid, except perhaps for the promise of Pool_God's gift of "Buy 1 get one free cocktail" when I finally save enough to afford his outrageous club fees?) to show folks around one of them governmental monuments.
Nope, not getting paid...but very happy to lend a hand...make sure you DYOR as you take a guide.
The navy blue now represents what I'm thinking as of today.
This one simply designates today!
Ok here it is. Updated comments below for a brief explanation on each point, do enjoy. (Note: If it's a bit small on your screen, try single clicking on the image below which should make it a touch more readable, I've skipped a few 'quieter' months to fit everything in).
The numbered points below pertain directly to the numbers on the Gantt chart above.
1. Pre Ind occurred on the 19th of Feb (US time) and PAR were happy with it. The minutes came out and we learnt a lot. In brief:
A) We need more numbers for the trial
B) We need to include a durability study, yes this adds time BUT at the conclusion of it, in my view, if we are shown to have a durability of greater than 9 months (and we have so far) then in my opinion this will be enormous news, it will have vastly positive repercussions for us in the fact that our labelling can officially state the duration if the drug and payers will be much more inclined to approve a higher drug price target and thus coverage on their part. ie Increased real revenue for us.
C) FDA implored and directed us to ONLY use the Bene compound, it was a big vote in favour of our chosen GMP FDA approved partner.
D) The FDA understands our uniqueness and moiety concept of the drug.
E) PAR attained certainty from this meeting, they know the way forward and that gives us confidence.
2. Well we are done with, let's call it the EPA exam! We made it. Mozz, why are you excited, didn't we just stick some needles into a tiny 10 American patients? That was easy. Wrong...we hand chose ten past American legendary football players....guys that were suffering, that had almost wrecked the bodies...some that have no doubt tried every remedy and are still suffering....This tiny sample size will be the lead indicator for how good our drug is. Sure we have had upwards of 1000 through the SAS program...but this is the first time officially that American patients are being dosed by our drug. Yes the exam is over...what are we waiting for? The results! See Point 6 for the continuation of this exciting point!!
3. Joint FDA/EMA equivalent of Pre IND mid March for MPS. It's quite an involved process specially dealing with not one but two separate agencies. The majority of these interactions were via teleconferences. I believe this series of phone calls has now taken place, not sure exactly where we are up to but hopefully we might get an update soon if it's pertinent.
4. Ok I originally was under the impression that a submission was imminent. This has changed significantly and now my revised rough date for submission stands in mid November. Why so late, well Paul did give us an update recently in April saying that it would be around Q4...I think they will wait at least for the OA Phase 3 IND and the data to come back from the WOMAC SAS batch(es). If it does get submitted in Q4 then yes, Mid 2021 revenue is a real possibility and Paradigmers, this will see a real lift in SP. One to watch for sure and at the AGM we can ask this directly for an update if we haven't had one by then.
5. Well with Point 3 covered at least to some degree, we can now speculate on when the MPS IND might be. Typically the time between a PRE IND/Trial Design submission and the IND is usually a few months. Conservative Mozz should add one month for the PRE Ind work to be done...and then a good two months to prepare for the IND submission...so that's 3 months...ie July...Aug..Sept...so that's how I come up with an OCT IND meeting in MPS. Its entirely possible to add at least one month to this process as we are coordinating with not one agency but two. But let's keep it to Oct for now.
6. I speculate that the result for the EPA program will be out by end of July. It might be slightly later but that's my view. This will be big news and the early signs (the update we had from two of the patients) are that things are looking good. PAR will ensure we garner adequate media coverage. It is at this first milestone that many will hear about us for the first time. The other pivotal points in my view are the respective start to Phase three Trials (OA and MPS) but in some ways, the release of data from the EPA will be a real eye opener and appropriate curtain raiser for us.
7. One of the bigger milestones, the IND for OA...slated for Q4...I'm being slightly conservative and pushing this out a little to November 2020 at this stage.
8. End November AGM time again, will be good to get an update at this stage and refresh my proposed timetable. (No change from the first Mozz Timetable). There is a chance this will be virtual meeting, let's hope not.
9. Just one little light blue square on it's own in the middle of the chart...but how significant it is. On achievement of this milestone we will be given the new keys to the car ...ready for our first drive! (point 10). This will make a large and impactful difference to the company we are, the underlying share price and it will be a real litmus test for what the future will hold for us and for the world we will one day approach.
When will we get the keys to drive our sales on the freeway of addressing OA?
10. Some estimated 10,000 patients could be treated in the first 12 months of getting the GO in Aus under the Provisional TGA program...it will be exciting times to watch the reports come in on each quarter's sales....Can't wait to see the escalating revenue graphs. As I've said in the past, this will be a blueprint for the much larger markets for us to get a sense on the future.
11, 12 & 13 I've reworked the order of these to try and better represent the timings of the MPS program Basically I'm guessing the MPS trial could go for about 8 months to 1 year... I've conservatively got it kicking off in December (hopefully it will be November 2020) and ending around August 21'. If we are lucky it will be sooner, if not then a couple of months later? Happy to get feedback on this or any milestone timing for that matter. Readout by Sep 2021? Then no doubt a few months to get the final labelling and marketing right and approved and then we roll.
The best thing about this program for us is that revenue will escalate rather quickly, quicker than OA. Why do I say this? Because it is a tight knit community that are in close contact with each other. Most of the patients live close to the hospitals and when one patient knows about a new working remedy....well it won't be long before they all do.
14 Ok this is the big one...OA Phase three trial. Once this kicks off the Big Pharmas will be itching to do a deal....it's going to be a long process though with the trial not expected to be done till 2022 sometime. At least we have a few of the other indications to keep us pre-occupied.
15 A newly announced trial on the condition of MPS I, to be conducted in Adelaide, Australia. I'll be covering this separately in the next few weeks.
16 Par also announced the commencement of a new trial in Viral Arthritis , I assume this is on the back of CHIK and RRV...I also assume this might commence mid next year?
Finally, as with the first installment of the timetable, all these below points are still relevant:
Additional points/announcements somewhere in between? 1- Peer reviews publications 2 - Possible DOD tie up with RRV/CHIK. 3 - Some other point I haven’t thought about, maybe some other MOA that’s discovered or some partnership comes about or discovery 4 - Additional SAS results though not sure if this will move the needle at all 5 - Massive news of distribution partnership (higher chance of this after Q4 2020 ie after IND for OA), the needle might break in this case as it explodes to the right with this news.
Remember, as always, just my thoughts here, everything subject to change, always wise to DYOR. I'll revisit this in a third installment perhaps at the end of this year to see how we are tracking along.
- Mozz
PAR Price at posting:
$3.54 Sentiment: Buy Disclosure: Held
The original plan...if it's still this colour, it means there has been no discernable change since we first visited the Mozz© Timetable.
This colour represents what the original was.
The navy blue now represents what I'm thinking as of today.
This one simply designates today!
(20min delay)