Jason4500, reposting original post here (see below) - editor's note: This needs to be updated somewhat as I originally was too optimistic (who me?). At the time I assumed incorrectly that we had like 20 days from the 11th Nov 2019 meeting, THAT meeting must have been to receive feedback and to actually subsequently submit our application sometime about now (usually within 3 months). It will then be up to 20 working days for the TGA to get back to us. I believe we are yet to submit our application, it's hard to get transparency on this as there is no real way to contact anyone at this stage to get any more info, so we still may have some time before the TGA or PAR announce the start of the program/granting of the Provisional program start if the TGA approves it. Again these are just my views, if I achieve any clarity over the next few days I'll be sure to post! . At any rate the target still is Q3 as far as I know, it might just be a fraction later in Q3 or slip to start of Q4, but it all depends on a few factors and hopefully no hurdles along the way!
Here is my original post back on the 26th of Oct: - - - - - - - - - -
Fellow Paradigmers, exciting times, though we have some amount of time to wait for the third phase to commence and then be completed but the Provisional TGA process is another kettle of fish entirely, read on for the exciting details...
Phase III is one thing, TGA provisional access will bemuchearlier revenues for us and once we have real legit revenues, we will come up on so many different radars.
We clearly got the wonderful message from PAR's recent announcement just yesterday that we could have revenue as early as Q3, 2020..let’s now investigate the details a bit more.
Referring to the TGA site itself,1we need to firstly determine what category we fall under.See table 1. below.
Table 1 - Application Categories under the TGA Provisional Program2
According to this table, I suspect we fall directly under category one. Yes we have a drug that’s already been in use for decades however, it is a re-purposed drug and in that regard it is still a new indication as the method of delivery ("new routes of administration"from the above table) has changed and this MOA is quite different from the previous pill format. The statutory amount of time is officially 255 days. But take a look at theaveragetime in the next table.
Table 2 - Prescription medicine application approval times for July 2016 -20172
Without getting anyone’s hopes up, there is achancethat wemayget clearance and approval a little earlier?In addition there is a pathway that is expedited by a further three months in the case of more critically required drugs.Now if you read the statement from PAR released just yesterday you get the clue they theymaybe trying to give us in that they first state that according to OARSI OA is a “serious disease” this needs to be established along with “significant improvement” for it to possibly fall under the expedited pathway by the TGA. Table 3 below gives us an idea of what are the criteria to make this expedited pathway, tell me what you think, will we meet the criteria? Time will tell!
Table 3 - Criteria for the Priority Determination to be eligible for an effective Fast Track.
If this were to be the case then July 2020 as a timetable for start of first revenues looks conservative! Wait Mr Mozzarc, I need more evidence: Again I refer you to table 2 above, check out therangetimes for approval, there is one drug that got approved in a Mclaren style 161 days (Greencircle)!
Not saying we will be off to the races super-car style, but there is a chance we will be accelerated if we present a good case and it is accepted.
Think of it as Australia’sownFast Track designation as this was the intention when the TGA first introduced it after the FDA and EMA had their respective accelerated programs in place. It essentially could shave up to a full 3 months of paper work. I’m not saying thiswillhappen in our case, all I’m saying is that thingscouldhappen quicker than any of any of us may realise.
Worst case in my mind even if wedon’tget this designation and we are at early quarter 3 for first revenue, this would still be be agreatoutcome. At the back of my mind I’m wondering that it could be even slightly earlier perhaps June 2020 applying the average of around 220 days from table 2 (Redcircle) above.
Paradigmers certainly exciting times just around the corner for us! As I’ve mentioned before, 2020 is going to be quite a year for us. All of my hardworking and diligent research teams and analysts (ok ok it’s just me then) are a buzz with new articles - much more to come! Yes there have been a few of these burning the midnight oil sessions, it does take time to read, research, check and compile such reports but let me assure you, it’s a labour of love, of course coupled with a vested interest but also a genuine passion aided by the wonderful positive encouragement and feedback from you guys. At the same time while making a buck or three we are making a large positive difference to patients lives, the stories just hear at HC are simplyinspirationalas well asinsightful. Don’t forget there are quite a few newer investors that have recently joined us that I like to cater to and sometimes I might get a bit repetitive. I do try and consider the negatives and not just blindly upramp for no reason. Yes I’m enthusiastic but we should be as the positives of this one beaut company make the little and few negatives negligible.
Finally the boring bits. You know, it’s always better to do your research, there always can be unforeseen hurdles whichcouldchange time lines and outcomes mentioned here. Don’t rely on anything I have said or researched these are just my thoughts and opinions, there is nothing likeyourown verification andyourown opinions to match your individual circumstances.
Fellow Paradigmers, exciting times, though we have some amount of time to wait for the third phase to commence and then be completed but the Provisional TGA process is another kettle of fish entirely, read on for the exciting details...
Phase III is one thing, TGA provisional access will bemuchearlier revenues for us and once we have real legit revenues, we will come up on so many different radars.
We clearly got the wonderful message from PAR's recent announcement just yesterday that we could have revenue as early as Q3, 2020..let’s now investigate the details a bit more.
Referring to the TGA site itself,1we need to firstly determine what category we fall under.See table 1. below.
Table 1 - Application Categories under the TGA Provisional Program2
According to this table, I suspect we fall directly under category one. Yes we have a drug that’s already been in use for decades however, it is a re-purposed drug and in that regard it is still a new indication as the method of delivery ("new routes of administration"from the above table) has changed and this MOA is quite different from the previous pill format. The statutory amount of time is officially 255 days. But take a look at theaveragetime in the next table.
Table 2 - Prescription medicine application approval times for July 2016 -20172
Without getting anyone’s hopes up, there is achancethat wemayget clearance and approval a little earlier?In addition there is a pathway that is expedited by a further three months in the case of more critically required drugs.Now if you read the statement from PAR released just yesterday you get the clue they theymaybe trying to give us in that they first state that according to OARSI OA is a “serious disease” this needs to be established along with “significant improvement” for it to possibly fall under the expedited pathway by the TGA. Table 3 below gives us an idea of what are the criteria to make this expedited pathway, tell me what you think, will we meet the criteria? Time will tell!
Table 3 - Criteria for the Priority Determination to be eligible for an effective Fast Track.
If this were to be the case then July 2020 as a timetable for start of first revenues looks conservative! Wait Mr Mozzarc, I need more evidence: Again I refer you to table 2 above, check out therangetimes for approval, there is one drug that got approved in a Mclaren style 161 days (Greencircle)!
Not saying we will be off to the races super-car style, but there is a chance we will be accelerated if we present a good case and it is accepted.
Think of it as Australia’sownFast Track designation as this was the intention when the TGA first introduced it after the FDA and EMA had their respective accelerated programs in place. It essentially could shave up to a full 3 months of paper work. I’m not saying thiswillhappen in our case, all I’m saying is that thingscouldhappen quicker than any of any of us may realise.
Worst case in my mind even if wedon’tget this designation and we are at early quarter 3 for first revenue, this would still be be agreatoutcome. At the back of my mind I’m wondering that it could be even slightly earlier perhaps June 2020 applying the average of around 220 days from table 2 (Redcircle) above.
Paradigmers certainly exciting times just around the corner for us! As I’ve mentioned before, 2020 is going to be quite a year for us. All of my hardworking and diligent research teams and analysts (ok ok it’s just me then) are a buzz with new articles - much more to come! Yes there have been a few of these burning the midnight oil sessions, it does take time to read, research, check and compile such reports but let me assure you, it’s a labour of love, of course coupled with a vested interest but also a genuine passion aided by the wonderful positive encouragement and feedback from you guys. At the same time while making a buck or three we are making a large positive difference to patients lives, the stories just hear at HC are simplyinspirationalas well asinsightful. Don’t forget there are quite a few newer investors that have recently joined us that I like to cater to and sometimes I might get a bit repetitive. I do try and consider the negatives and not just blindly upramp for no reason. Yes I’m enthusiastic but we should be as the positives of this one beaut company make the little and few negatives negligible.
Finally the boring bits. You know, it’s always better to do your research, there always can be unforeseen hurdles whichcouldchange time lines and outcomes mentioned here. Don’t rely on anything I have said or researched these are just my thoughts and opinions, there is nothing likeyourown verification andyourown opinions to match your individual circumstances.
Table 3 - Criteria for the Priority Determination to be eligible for an effective Fast Track.
(20min delay)