Ok..let me go first, a few of you will no doubt think I'm too biased but remember, I'm always wanting to hear the negatives....we must hear negatives so we can either iron them out, tackle them or work out what the next step is.
Yes I come across as HIGHLY positive on PAR, but don't for one minute think I do not entertain negatives....I discuss them almost on a weekly basis with a number of contacts. I have had a few scares before in the past with PAR. All doubts so far have been suitably quashed (in only my personal opinions). I have a few peeps dedicated to look for only negatives. I've held since 2015...but really started researching properly for the last 4 years.
The overall goal that we want here is to achieve those Primary Endpoints on a safe and efficacious manner and trump that Placebo effect. Full Stop.
But there have been other examples where drugs have failed their primary but achieved the secondary, my classic go-to is Sirtex. They failed their primary but went onto have meaningful revenue (despite a number of other mis-steps) and eventually got taken over for a princely sum of $2 B AUD. I should know, I was a shareholder.
Around 50% of P3 candidates don't make it...
NME = New Molecular Entity We are repurposed so we wouldn't fall into that category.
So some 67% of the ones that make it to a PIII will get through to an NDA. After that the chances are greater that we will get licenced.
BUT, to get back to your burning question...what would it take for us to FAIL??
I would normally definitely put my hand up and say a fatality...a very very serious bunch of AE's...but in our case, I'm not even sure that a fatality would stop us totally.
WHY?
Because we do so much good and we do it safely and there isn't anything else out there that addresses pain....OA...inflammation. This is something not seen before...at such scale, with such incredible percentages...88% of SAS patients to date have got SOME benefit. The horrid opioids give barely 15% on average pain relief...pathetic...we are at 51% or so.
The single best example I can give you is again, Humira..
Yes, believe it or not, for a drug that has some $200,000,000,000 in revenue so far ($200 Billion, I had to type it out in full)...do you think they have had any fatalities.
Mate, prime time for a Mozz quiz but I will skip it and just tell you..
..it wasn't just a handful of deaths if you were wondering....
10,884 DEATHS and counting.
This is why I don't think our P3 not making it is on the cards and if we dont, I think there will be some major revisions to allow us to have another well, re-trial in legal speak..
Of course I'm not totally crazy, such a very serious AE wouldn't be great for our low share price..we can drop a number of rungs from here if there were real problems, I'm not under the illusion that there is NO risk! The good thing here is that out of 100,000,000 injections so far, there hasn't been
any fatalities. Not even those poor heavily dosed up rats...many times the human recommendation equivalent.
Some other common reasons for failure are here:
Again, going through each section, I cant see there being problems for us, we at least so far are tracking along nicely... but coming back to the question, things can still go wrong. There could be some major stuff up or problem...we did see changes to management that were unfortunate and that NONE of us anticipated. Yeah we lost some momentum. That was out of left field for sure...yes we addressed it quickly...but it does serve as a warning...never invest too much in one investment vehicle no matter HOW good it sounds!
My other rule is to imagine if it went to zero...where would we be...what would need to change....hopefully not too much for you as an individual.
Happy to hear what other's think...
DYOR important
References
1)
https://www.parexel.com/application/files_previous/5014/7274/5573/ACT_Article.pdf2) https://www.drugwatch.com/news/2018/06/12/humira-deaths-put-abbvie-on-fdas-radar/#:~:text=Patients%20Claim%20Deadly%20Humira%20Side%20Effects&text=Since%202003%2C%20the%20FDA%20received,lawsuits%20over%20Humira%20side%20effects.
(20min delay)