Fellow Par Investors, time for an update on the comparison between us and CUV
1.
Original Comparative Post: https://hotcopper.com.au/threads/par-v-cuv.4747202/The FDA has given October 6th as the date it will publish its results on the Phase III trail for CUV. This isn't a cross post asI am using CUV (as 51 Cap has in the past) as an excellent example of a fellow Australian Phrama company that's ahead of us on the path to commercialisation albeit in an unrelated medical field.So where are they up to? Well have a look at this, their share price currently around $27, at the time of my original analysis it was at $24.48 (25th June 2019). Though that might be interesting the real comparison is market cap to market cap. CUV is currently $1.33 Billion, PAR is at $300 Million, that's 4.4 times. That 'only' equates to $7.10 for us.See how much growth prospect is built into their share, although they do have revenues coming in.
Conversely, see how conservatively we are trading. I attribute our undervalue, at least partly, because we are so unknown to the market in general and also because we are some ways off the Phase III result for ourselves, hey we haven't even submitted our application yet and it may not happen till the end of this year (or possibly start of next year in my mind).
The other comparative I want to give you is the timing. Its a bit harder to compare our two companies as our basic compound has been in the market for some years already (ok ok for some decades already!). Theirs is quite novel, let me quote from their CEO who claims their solution, being evaluated by the FDA is"a novel systematic photoprotective therapy, the world's first injectable therapy"
2 . Ours is a repurposed drug and plus the current std of care in our case is killing 900 Americans per week
3.
CUV is at a Priority Review Status with the FDA, I believe as mentioned previously here at HC, we could get either Fast Track
4 and/or Breakthrough
5. The Hot Copper Par fellow poster, Whitta
6 asked the question if two designations are possible at the same time? I'm finding it difficult to find specific literature on drugs that have managed to be assigned two at the same time but I'm speculating that such a company would primarily apply for one (eg Fast Track) and then subsequently might be awarded another (such as Breakthrough) at a slightly later time? In the following journal there is some reference to the ability to be able to apply for more than one designation at a time "To qualify for
one or more of these FDA programs, a sponsor must meet specific criteria."
7 Also according to the FDA's own website one could surmise that it is certainly possible to have a couple of designations. A BreakThrough designation actually incorporates the Fast Track benefits:"A breakthrough therapy designation conveys all of the fast track program features... more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review"
8 Back to my point regarding timing, CUV submitted their application for Phase III in January this year, with a Priority designation in place, they are getting the results in October this year.Not bad, 10 months.
Our case may be quite different as mentioned we have a drug already in market (we seek approval for an Injectable as opposed to Pill format), the needs for OA are obviously different compared to CUV's skin product so its not an Apples to Apples comparison but it does give us some clue as to how long things can take. Lets see what happens to CUV's SP after the Trial III result comes out, again its a bit of a window as to what may happen in our case.
As usual my opinions, please do your own research and formulate your own views. Exciting times none the less.
References
1) https://hotcopper.com.au/threads/par-v-cuv.4747202/
2) https://www.asx.com.au/asxpdf/20190820/pdf/447mmgqw64f8kv.pdf
3) https://www.cdc.gov/drugoverdose/
4) https://hotcopper.com.au/threads/fast-track.4780603/
5) https://hotcopper.com.au/threads/breakthrough-designation-defined.4924437/
6) https://hotcopper.com.au/threads/breakthrough-designation-defined.4924437/page-2?post_id=40142660
7) https://journals.sagepub.com/doi/abs/10.1177/2168479016666587?journalCode=dijc
8) https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
(20min delay)