This morning I thought it would be nice to come up with not just a timetable for a particular stream but the multiple streams we currently have on. At some stage we will be in a better position to assess this as well as any possible new indications but at this stage our thrust is firmly with dealing with OA and MPS. These two are no doubt generating plenty of work at PAR Headquarters.
In reality it’s a difficult task to come up with a time line as there are just so many hurdles and factors to consider. So far we have had a few delays due to varying reasons so it is best to err on the conservative side and even then you must be prepared for blow outs in terms of schedules and milestones. With that, let’s try and have a rough go just for fun! Happy to hear your version too!
We are here today are in the last week of Feb.At the moment we just had our Pre IND with the FDA in terms of OA. At the same time we have had our first American footballer being dosed with iPPS under the expanded access program.
Some notes with the below: I had to 'skip' a few months as it wouldn't fit in one screen. Click once on the below image to enlarge it if it's too small. Refer to the numbers below for a descriptive of my thinking and further notes. The # Numbered points in the Gantt chart/timetable relate to my descriptive points below.
Let’s timeline this up:
1. Pre Ind occurred on the 19th of Feb (US time) and PAR were happy with it. We are now waiting on minutes which will happen within 30 days of the meeting.
2. Well we are off and running finally with the Ten American patients. Mid may last American footballer patient dosed, so this gives us a good idea of when the program ends. What we don't exactly know is how long it will take to compile the results and 'read out' the data and present it to the press. No doubt there will be a few interviews lined up by the project lead and lead doc (Mitch and Dr Michaels)
3. Joint FDA/EMA equivalent of Pre IND mid March for MPS. Its quite an involved process specially dealing with not one but two separate agencies. The majority of these interactions will be via teleconferences and there will be a fair amount of work to not only prepare for this but there will be lots interaction both ways. A time consuming process and I would expect it to go for months before we are in a position to have a trial design ready to go and the equivalent of an IND is set.
4. I’m hoping the TGA submission happens soon and they get back to us in 30 days to start the process for provisional approval, this 30 days should end around end March, let’s call it mid April?
5. June typically how long it would usually take for IND for MPS but maybe we should add at least an extra month? Let’s call it July. This could well be further delayed due to trail set up/design and organising patients from multi centres/countries. Don't be surprised if this gets delayed by an extra month or so. There is a fair bit involved with having two agencies at work and coordinating between the three of us.
6. July results out for Footballers, again subject to lab and how long it takes to compile the results, can easily see this falling to August as well.Media coverage sometime in end July? Don't forget it may not just be one press/media release/interview, it could be a few. Would be good to take advantage of more than just one interview via TV/Other such media channels.
7. Ind for OA is supposed to occur by Q4 but I will say it’s October to build at least a little fat in in case we are delayed a fraction? This could be a good month for us if we get a Fast Track or some designation like this?
8. End November AGM time again, will be good to get an update at this stage and refresh my proposed timetable.
9. We should get TGA approval some time in Q4, let’s go conservative and assume it’s mid Dec, exciting time and I will take this news, if it happens by Christmas, as my Christmas present.
This takes us to 2021. Gosh if you think 2020 was busy, 2021 will be busy and exciting! I haven't gone into too much details from here onwards as there is a lot involved and it is subject to a lot of the tasks and milestones occurring at various times within 2020, anyway here is a snapshot:
10. February or March 2021 could see us getting our first ever revenues from patients here in Aus, will start with just a few patients hearing about us early on, but I think in two to three months time from there it will start getting significant ie around a few hundred to low thousand patients, after another 3-4 months it will be well into the thousands ...this could be around September 2021...hmm Christmas 2021 might be a good one for us!
11. February we just might get approval for MPS? Remember, being an Orphan indication would automatically put this on a faster path than just a 'normal' drug on a FDA pathway, I’m giving it a full eight months for trial design primary and secondary end point determination and approval and coordination between US and Europe for perhaps 30-40 patients? Perhaps eight months is a little optimistic let’s bump it up to 10 months this now puts it at April 2021.. This will definitely “beat” OA in terms of third phase read out timing I’m guessing.
12 & 13. Revenue from sales of MPS iPPS will start maybe around three months after the read out as FDA will need to work with us in terms of marketing and labelling, so realistic revenue start by perhaps by August 2021?
Finally. OA read out, we have to be fairly conservative because the IND is not until Q4 2020. One would have to allow a minimum of one year for this entire process of third phase trial to play out and up to 18 months is also likely without a Breakthrough or Priority type designation. This puts us closer towards the end of 2021? We don’t know what designation we get, if it’s a Breakthrough halfway through the trial or the trial gets closed early due to extremely positive results then of course this could be brought forward. Again better to be conservative and go with a later date, let’s be pleasantly surprised eh’?
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.
Disclaimers
Highly speculative info here, very much my own thoughts and ideas, I may have it totally wrong and of course you should in no way rely on this information in any way. No one knows the future, things can change quite quickly, there can be massive unforeseen hurdles, as an example if there is a clock stop or FDA take slightly longer to get back to us on some point then timeframes and milestones can fluctuate wildly. Working with two agencies can also add to the delays if it isn't coordinated well or subject to timings as one needs more details etc. DOYR of course.
(20min delay)
