Description
Strap onto your seats, this will be a wild ride.
Babe Ruth was known for pointing out his home-runs before hitting them.
In my case, my pointing will be more due to the luck of finding the investment profiled below, PTIE.
As I explain below, PTIE will probably exceed $50/share within 2 months if the FDA approves its lead drug candidate, Remoxy.
If I am wrong, it will approach $0.
What's even more interesting, however, is that this Tue, PTIE will present its argument for approval of Remoxy, to an FDA Advisory Committee.
See: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm608768.htm
Why is this important?
Look at PTIE's chart in January of this year.
On Jan 9, 2018, PTIE spiked from ~$4/share (prior close) to $13/share because they published the following: http://investor.paintrials.com/news-releases/news-release-details/pain-therapeutics-reports-positive-top-line-results-nasal-abuse
As this mostly public meeting will be PTIE's chance to explain to the FDA why Remoxy, should be approved, I think the probability is better than not that they will present, highlight their most compelling data.
I say "mostly public" meeting because the first hour of the meeting will not be public and the public portion will not be webcast. But the material will be published by Monday and perhaps tomorrow.
So why do I think the data will be compelling?
3 reasons:
1. PTIE has not raised much equity and is running out of cash, i.e. this shot looks like their last. The CEO owns ~20%. They could have sold a lot of equity in Jan 2018 because they had the data from their Jan 2018 release well before it was released and could have used their ATM with Jones Trading.
2. They have shown skill by obtaining $6 million in govt grants in 2017 to develop their drugs
3. Their VP of regulatory affairs returned to PTIE from a similar position at Impax. One could counter that this VP returned prior to PTIE's 3rd Remoxy CRL (rejection).
A skillful company would not risk its viability when it had the chance to avoid such risk (i.e. dilute) if its only compelling data was in the Jan 18 release.
If that was the best they had and they had serious doubt about approval, they would have raised equity to diversify risk by developing other drugs.
I do not hold a position with the issuer such as employment, directorship, or consultancy.
I and/or others I advise hold a material investment in the issuer's securities.
Catalyst
data published/presented at: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm608768.htm