Paradigmers, Today we got a bit of an update and an insight via the Quarterly Update. I've been looking forward to the update in terms of the TGA submission. In light of this, tonight let's traverse through some of the possibilities that
may play out for us...Traffic light style...
So as per usual, remember that these are just my musings, my speculation, a lot of scenarios can actually play out and there definitely could be hurdles or even some things that work out faster?
THE TRAFFIC LIGHT ANALYSISOk I know you are curious about this...what I mean is let's take three broad scenarios...a pessimistic worse case scenario (
RED)....a more realistic approach...(
AMBER)...and finally all is great (
GREEN) for the quickest scenario that might play out...
RED - PESSIMISTIC
Ok worst case scenario...So we wait for the FDA Type C meeting notes "...the feedback from the FDA is indicated to be received toward the end of Q4 CY2020" (From today's Quarterly) ...even this gets a bit delayed and we have it mid Jan....after another 3 months we finally submit for TGA provisional as perhaps there are some modifications and adjustments to the trial design or some extra communication between PAR and the FDA takes place to get things just right, to get the registration perfect so it is crystal clear...so that means submission to TGA by April end...
Now the legislation provides for 255 working days (See Appendix below for details) ...the median time is 202 days but we are in pessimistic mode so we take 250 days *ugh*..that equates to a fairly ugly and long 51 calendar weeks with a few public holidays thrown in....Crickey, that's almost a year...so we are now talking April 2022...
AF, you will have your work truly cut out entertaining us all so that we don't go batty mad (not saying I'm not that already).
Mozz after 1 year still waiting for TGA...I don't think I like red traffic lights....let's try Amber...
AMBER - REALISTIC
Ah Mozz...this is the bit where we have to be REALISTIC! It should be the most probable pathway. Remember, these are just guesses and I'm very happy for others to weigh in with their thoughts.
Rightio so under this realistic scenario...PAR hear back in the last few days before Christmas....they will then need some time to organise their final application in light of the official words from the FDA, in fact don't forget there could be a little adjusting here and there and some communication which we should factor in. Let's give them 2 full months after that for PAR to finally submit...let's say end of Feb 2021.
In a realistic scenario, the TGA will take about the median...so that's 202 working days...that equates to 41 odd weeks with a few of those public holidays in between. 41 weeks from Feb...that's 9.3 (let's go 9.5) months...that's the very end of 2021. Realistically you'd have to go mid Jan 2022.
Most probably this is a rough target for us.
Ok time for some dreaming.......
Go Green traffic light....Rev those engines...
GREEN - OPTIMISTIC
I refuse to rule this scenario completely out so I will not go crazy in this case, we might as well try and come up with something realistic...I'd rather UNDER promise and OVER deliver, correct? I love the bonuses..I love the surprises...Might as well have it in our minds this will take longer and then all be pleasantly surprised.
We hear back from FDA by third week Dec...we still need 2 months to prepare the final submission to the TGA...that still puts it at about Feb...let's sneak it into the last day of the 3rd week of Feb (Go PAR!?). Now the median time for the TGA to pass us is 202 days (See Appendix below)...the range has been as little as 141 days and a max of 249 days.
I'm reserving the 141 days for life and death drugs so I don't think there is a very good chance of us falling into that basket despite the argument of opioid death and OA being a very serious and painful condition whereby lots and lots of people in Aus are suffering.
BUT, TGA do have some good evidence of our little magic so far...some almost 1000 patients through already, the SUPER big guns of FDA and EMA simultaneously declaring we have a real case (the EMA already giving us a clear path), we don't need a third active arm and a clear path to possible success being formulated as we speak...this all has to add
some weight, have
some bearing on a slightly faster smoother pathway? SO let's take it at just under the median...let's go 185 days. That's 38 weeks (with one week of public hols added). 8.5 months ....so we are adding that to end of Week 3 Feb....this gives me Mid November 2021...hmmmm just sneaking it on to the market before Christmas? Whaddya think?
FLASHING LIME GREEN - WHEN DO WE EVER SEE THESE?
Yeah here's my no-way-is-this-going-to-happen scenario....just ignore this next paragraph, it's just me having my fun....
It's the Lime Green Traffic light on flash that perhaps doesn't exist! PAR hears back end of Dec...they submit by end of Jan (not sure about how that is enough time but read on)....the TGA say "
Bro, we got mountains of cracking evidence from you guys already, you guys deserve stardom...".They get back to us in just 170 days...it's almost like a priority designation (which they actually do have, there is at least
some chance we might meet their criteria for this label but I haven't included it into these scenarios).
170 working days translates to 35 weeks...add this to end of Jan and we are at the start of Oct....hmmmm I don't rate it...prob 10% chance? Least there
is a chance but most things do get delayed for some reason or the other. At least
AF won't have to work quite as hard for us in this case?
Don't forget...this is ONLY TGA Provisional I'm talking about, Yes it would be early sales, but worst case it will hopefully be early 2022...there is a lot else going on....MPS is the other
big one in my mind as it is quick (compared to the OA trials/program) and that has a REAL chance of striking a deal with a bigger Pharma as we get through next year and first sales draws excitingly closer. A partnership, even a localised one, would mean instant awesomeness in terms of a share price re-rate...
DISCLAIMERSAll my work..my thoughts...don't read too closely into this...it's a rough...As I said there can be hurdles and the submission will no doubt hinge, as
GanGans has mentioned, on the outcome of the Type C meeting and the robustness of the said trial design. If this is a smooth process then hopefully it won't be too long after the feedback that we are in a confident position of submitting...
Your own research is best policy...and one more thing...obey them traffic lights on the roads, do stay safe.
APPENDIX
TGA Approval times for Cat 1 drugs
REFERENCES
1] https://www.tga.gov.au/book-page/1-prescription-medicines-2
2] https://www.policymed.com/2018/03/fda-issues-new-draft-guidance-on-submitting-formal-meeting-requests.html
3] https://www.fda.gov/media/72253/download
(20min delay)