Forum Topics PAR PAR ASX Announcement
Chagsy
Added 2 years ago

Study results.

good bits and bad bits: it looks like the main thrust of the study was to show that markers of disease (knee OA) would be modified by the intervention (the study drug). This did achieve statistical significance for a couple of markers.

It was also demonstrated that some imaging findings on MRI were significantly reduced.

the study was not designed or powered to demonstrate an improvement in clinical symptoms. And indeed they did not achieve statistical significance. But it was very close.

I think you can read into this whatever your bias wants you to read.

As with all of these drug development companies, it all boils down to the phase3 study. This will be expensive and is many years away. The additional risk is this essentially a single drug company; so the risk is massive.

The upside is also massive if they pull it off, but Ive been burnt too many times before - so not for me.

If you REALLY want to be an early investor(before definitive proof is available) I would suggest waiting until the phase 3 study is funded enrolled and nearly complete before entering. and even then accept that, at that point it is a binary outcome and you could basically lose everything.

Not Held. but really interested to see how it goes!

21

GazD
Added 2 years ago

Good discussion @Chagsy and @Invmum

@Invmum you are correct that many of the endpoints discussed did not reach statistical significance but this was never the intention of the _008 trial and was not powered to demonstrate any one outcome unequivocally. Small numbers make statistical significance difficult to achieve unless the effect size is massive. Taking a step back, whether a given marker was different to a p value of <.05 or <.07 shouldnt actually matter much in this type of study. The trend across the board of effect in the same direction demonstrates a biological effect in my view. Happy to accept that I'm biased as a holder but all the data so far supports an effect on pain and function and is suggestive of Disease modification.


@Chagsy Your call that a single drug company is high risk seems pretty fair. All that I would say is that if you explore the risks (two key ones being: Is the drug safe? Does the drug work?) I think you can have a degree of confidence higher than that open to you with an earlier stage pharma with novel compounds (ie range of outcomes is already much lower with this old compound).


The TGA, FDA etc will demand greater numbers to grant an indication for disease modification, as they should.

12
GazD
Added 2 years ago

I’m an anaesthetist:

so arguably no particular expertise with this drug,

however, my bull case is a follows:


  • Pentosan polysulphate has a long history of safety in treatment of cystitis
  • There is a lot of evidence that it works in OA to reduce WOMAC scores (which means less pain with basic activities of daily life) - I’m confident that the current pivotal trial will demonstrate a clinically effective response (but clearly the opposite outcome would be a showstopper)
  • there is biochemical evidence to explain the mechanism of action and biological plausability
  • i agree with your tendency to see osteoarthritis as a lifestyle disease but that isn’t stopping people making poor decisions and obesity is not going away.
  • in addition there is a strong push away from opiates in the pain and medical community which bodes well for alternative analgesic options
  • cream on the cake would be evidence of disease modification from the 008 trial. To my knowledge there are no pharmacological options for modifiying the Disease process in OA at this point in time


these points are the short summary of my bull case

@CanadianAussie by the way thanks for engaging! Appreciate it!!!


25

GazD
Added 2 years ago

Oh and I know everyone will laugh at this (and possibly they should) but huge TAM!!!

6

occy
Added 2 years ago

I feel stupid for asking this but could you please elaborate on what 'TAM' is? I feel very OOTL on this one.

7

occy
Added 2 years ago

Cheers Bryce

5

GazD
Added 2 years ago

It is snake oil isn’t it, but sometimes it isn’t? How to know

5

edgescape
Added 2 years ago

@Strawman explained this some time ago with BRN.

Basically most companies use Total Addressable Market as one way of valuing a company on the assumption that they can generate future cashflows on the basis that they can capture that market they are targeting.

In reality they may only achieve a fraction of that TAM. This may be due to risks and events or other factors outside and inside the company which occur and makes it hard to reach that goal.

I could go on but I don't want to add further confusion to this subject.

At the end of the day a company has to try and make money and provide positive returns to stakeholders including creditors, employees and shareholders etc. no matter how much the target market is worth or how much it is growing.

I used to use TAM but usually ignore it now.

12

Shapeshifter
Added 2 years ago

I would suggest that the sucess of pentosan plysulphate sodium as a drug to treat OA will hinge on it having a significant disease modification ability.

Pain management alone would probably not be enough.

As @GazD mentioned PAR is attempting answer this with their PARA_OA_008 Study. Although they have reached 100% recruitment for this study it is only a phase 2 clinical trial with 20 subjects in 3 different treatment arms. Not big numbers.

Having said that top-line data from day 56 endpoints remain on track for release during Q3 CY22 and if these come back positive this could be a signal to start geting a position in PAR if you were interested.

(Not held)


13
CanadianAussie
Added 2 years ago

Hi @GazD

It might be easier to discuss questions in the forum. I'm far from an expert but will take a crack at your questions seeing as no one else has.


Q was the 10% uptick related or just the general sentiment on the market today?

A I'd suggest if there was no material news it's probably impossible to tell why buyers were willing to pay a higher price all of a sudden. Personally, I wouldn't value the company 10% more valuable based on this news but that's just me.


Q 2,000,000 shares were issued to Marc Polizzi the recently appointed CEO. They are staggered to come out of escrow in one year, two years and three years?

A Yes, this appears correct. PAR shares traded at a low of $0.98 at the time of the announcement and it appears these have been issued at $0.96 which seems reasonable.


Q If the outstanding shares are 230 million as listed on yahoo finance this equates to just under 1% of the market cap of the company... If this is in lieu of income then I'm in favour, after all they need to conserve cash until they get the phase 3 trial done and are able to partner up, get bought out or actually go into production/profitability...

A You might want to email investor relations and ask. If it's in lieu of income I'd be very happy with that as a shareholder. If it's not, I'd need to know what his salary is. However, considering it's <1>


I'm no longer a shareholder but if I were I wouldn't see this as significant news. A mild positive he holds some shares now but would be much happier seeing him buy on market.


As a doctor, I'd love to hear what you're excited about with Paradigm? Are you an orthopedic surgeon? As a physiotherapist I'm very skeptical of companies offering treatments to alleviate pain, as I'm sure you'd be aware pain can be quite subjective. Whether correct or not, I also believe a lot of knee (and back) pain is a result of the nocebo effect and resulting lifestyle choices; both of which do not require surgeries or medications to remedy.

18