PAR (ASX) TGA

Originally posted by Mozzarc: ↑

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 Program}²

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 -2017}²

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.

Last edited byMozzarc:26/10/19

Expand

I think the current risk to the share price is that we don't meet the "first revenues" commitment for 2020.

The dossier has not yet been submitted and as far as I can see PARs application as being able to be expedited has not been confirmed yet, so the timing is unknown.

There is also the lead time to obtain stock with the Australian CMI/PI inserts that does not seem to have been factored. This work can only commence upon TGA final approval.

Notwithstanding possible short term delays, I purchased today as even at today's prices it looks a compelling case for the longer term.

No.	Vol.	Price($)
1	1325	24.0¢

No.

Vol.

Price($)

1325

24.0¢

Price($)	Vol.	No.
25.5¢	29564	3

Price($)

Vol.

No.

25.5¢

29564

No.	Vol.	Price($)
1	1325	0.240
2	20000	0.235
8	234156	0.230
5	125884	0.225
15	272054	0.220

No.

Vol.

Price($)

1325

0.240

20000

0.235

234156

0.230

125884

0.225

272054

0.220

Price($)	Vol.	No.
0.255	29564	3
0.260	2500	1
0.265	30000	1
0.270	37829	3
0.275	13636	2

Price($)

Vol.

No.

0.255

29564

0.260

2500

0.265

30000

0.270

37829

0.275

13636

(20min delay)
Last 25.5¢		Change 0.005(2.00%)		Mkt cap ! $89.19M

Open	High	Low	Value	Volume
25.0¢	25.5¢	23.5¢	$105.4K	437.7K

TGA, page-22

Twiggy Forrest to acquire 40% of native hydrogen explorer – not long after putting Fortescue Future Industries to sleep

Infini rolls on with soil sampling at Portland Creek not long after making possible 'uranium history'

Talga expands Prospectus Offer to $9M, banks $18.5M overall since end of financial year

Emerald expands underground resource by 105Koz at Cambodian gold mine Okvau

EBR reaches review milestone for wireless cardiac pacing device

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News

TGA, page-22

Top Stories

Twiggy Forrest to acquire 40% of native hydrogen explorer – not long after putting Fortescue Future Industries to sleep

Infini rolls on with soil sampling at Portland Creek not long after making possible 'uranium history'

Talga expands Prospectus Offer to $9M, banks $18.5M overall since end of financial year

Emerald expands underground resource by 105Koz at Cambodian gold mine Okvau

EBR reaches review milestone for wireless cardiac pacing device

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News