New orphan drug designation, page-10

Ok, some potentially very good news here.

A few new guys to us...a short recap if I can.

ORPHAN DISEASE

Basically means a rare disease...rare is 1 patient out of 200,000 (US definition) or less.

Usually companies won't go for such solutions as the market is just so small...so the FDA has incentives to make it more lucrative, some of which are:

1) Increased amount of time for exclusivity (not really a big incentive for us as PPS has been off patent for years and no one has managed to copy us and we have discussed patents at length etc). 7 years is the std. amt of time anyway.

2) Tax credits, there is roughly a 50% reduction in fees, no this isn't like $450 off your council rate as you are a pensioner, it's in the millions of dollars.

3) Probably the biggest incentive for us Paradigmers, is the simple fact that the dialogue between us and the FDA gets opened up much more than a normal pathway. Why is this good? We we get their time, we get to ask questions and get answers quickly. Its a bit like being treated with your own personal banker...a dedicated banking liaison so you get priority access to those concert tickets or funding is a little easier or you just call up when you like, even after hours and someone answers...*dreaming* my style of banking when we hit $50 + on these shares perhaps?


Share price increase? Well as an FYI, the average % increase in any given share price for these sorts of designations is as follows:
"The results, on average, show that the stock price of a company increases by 3.36% after the announcement of the designation, increasing the value of the company".¹

But smaller companies do get better lifts in general, "The results are more pronounced for oncology drugs, and drugs being developed by the smallest companies". ¹

Another quick fact...how many Americans have some sort of rare disease? I would've guessed it to be...

220,000...just a Mozz guess...answer?

"The total number of Americans living with a rare disease is estimated at between 25-30 million". ²

Its actually big business and estimates are that its worth around $1.4 Billion to us...sure that might be a few years away...but it's a big carrot in its own right. Of course it ain't JUST about the numbers, these patients are suffering...NOTHING out there now gives them relief like we will be able to (My views)...and we wont cause more damage (My views).


Lets see what awaits us tomorrow! Exciting. Gosh if we think this is good what will we feel when we get approval...when we get revenue...when we come on to real radars and of course when Absent-friend is allowed to post you know what...?

My Views


<sup>REFERENCES

1)</sup> https://ojrd.biomedcentral.com/articles/10.1186/s13023-017-0665-6
2) https://rarediseases.info.nih.gov/diseases/pages/31/faqs-about-rare-diseases