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To be fair pzott helped me be cautious with this one (highlighting their previous for dilution). I ignored him and bought anyway on approval run up but then I sold out on the approval spike first thing. I would have normally held half but I kept thinking of some of the links posted so got out. Its healthy to take on both both bullish and bearish views and form your own opinion.
Everyone is just busy with PLTR. Good to see this one moving in right direction though. This one is going to be a hero or a zero.
Seems a little busier than normal. Lets hope some news is coming.
Up quite a bit this week despite still being a sleeper.
I was very positive about this company years ago and the entire prodrug thing (my money was tied up though) - then I think they got themselves bogged down in the entire opiate market mess - even though they were trying to solve the the opiate crisis with their technology the entire sector just became toxic and that cost them big, and I feel for their shareholders back then that got creamed.
Looks to be through to the other side now and the mess cleaned up - though I do understand people being wary. But this wariness is way overdone in the low share price. Weeks from potential approval for a maybe huge sales drug (and with pipeline) and valued at 100m (give or take 20m) or so. What???!!! There's companies who are not even into Phase 2/3 with a smaller market drug with a market cap more than that.......
I'm not recommending anything and win as much as I lose - but hopefully this one works.
PZ - thanks for DD and I hear you. I'm still going to risk it short term because of the science.
On a side note - it's really annoying to watch these companies pay their execs ludicrous salaries when they haven't even succeeded yet. That's the whole point isn't it - you should make your money when your shareholders make their money and not before hand by being greedy.
To each their own. I went long. But this judgement call was based on the science - I'm familiar with prodrugs and what they have looks solid from a chemistry standpoint. Prodrugs have less clinical risk as the underlying drug will have a ton of clinical/market data. All that has to be proven is the ligand molecule detaches (or remains attached when you want it to) for the anti-abuse claim. They did that with Vyvanse.
I also like their partnership with Corium - the CEO of which - happens to be the ex head of US commercial (and head of global neuroscience which would have been ADHD) for Shire who built the huge ADHD market. This is a very good sign - means there is real commercial knowhow there. Shires (takedas) multigeneration rule of ADHD will be coming to and end 2023 sometime when vyvanse patent runs out. Vyvanse is also a prodrug. They bought this prodrug from New River back in the mid 2000s for +2b. Guess who makes up the Kempharm guys? Yep - a bunch of ex New River peeps.
The negative I can see is it looks like they have messed with their long term loyal shareholders over the years. So I'm in short/medium term but don't know if I'd trust them on a long term hold.
I'm not sure what to think of this one. Seems like a good idea but not much love for this company.
They appear to be the New River Pharma guys under a different badge.
I'm presuming its all 505B2 regulatory pathways.
I'm loading this. Reasonably confident in approval. My target is 13/14/15 or so - same as the analysts. Anyone know if they have enough cash on hand to take them through the summer - sorry I could look and that sounds lazy - but hey if someone already knows great.
My plan is to sell half in week after approval (as I am pretty confident). Then hold half. I'd like to hold all but I need some liquidity to trade the next one.
Thanks for all info. Been hovering on here for a while. I'm reasonably confident this will get approved.
Cheers mate. I'm CMC/facility approval, FDA interaction background with a friend with clin experience. No idea on the financials though so a bit blind. I really appreciate quick thoughts.
New here so sorry for dumb question. I invested in this one a week or two ago after reviewing some of the scientific and other data. Since I'm not much of a technicals/financial guy is there any idea of what would be a reasonable price target now its approved.
Now 0.006. All over the place. Oh dear.
Last trade 0.04 so up 33%. My data could suck though.
Do you have a link?
Yeah - sorry for repeating what everyone else asked - my browser jammed on yesterday.
What's going on? 128 million volume by lunch.
I am one of the Muppets that bought in at 2 bucks and held. I assumed there is no way they could let it fail as it is the only major vertically integrated fully USA based manufacturer of pain meds (after Purdue went down). Despite pain meds being out of favor they are still needed. We may see a bit of a problem in the healthcare system now.
Thanks for the advice. I have an interest in this company over the long term. I see two interesting things:
OSA - this appears to have been stuck for along time. Could it be going somewhere now? Even a 505b2 Phase III is not that cheap - I hope this can be initiated sometime in the near future but lets see.
ADHD - I am a little more familiar with this space. If they resurrect that one that could be very interesting. Vyvanse is open to generic competition sometime in 2023. This would potentially spell the end of the ADHD adderall then vyvanse franchise which has been going on for decades.
I'm pretty sure if they were in the middle of phase 3 going smoothly it would be worth a lot more than a penny. More like a dollar or two.
I can't see any references to phase 3 on clinicaltrials.gov
Phase 2 - yes - that has completed.
I haven't seen that info released.....
I had no idea they had started phase 3.
Anyone know what is causing this today?
Researchers reviewed 18 studies examining condition obstructive sleep apnoea.
They concluded that it is an additional risk factor for death from coronavirus.
https://warwick.ac.uk/newsandevents/pressreleases/covid-19_patients_with
https://www.sciencedirect.com/science/article/pii/S1087079220301258?via%3Dihub
They are clearly saying what they plan to do.
OSA will be 505b2 - much reduced phase 3 clinical cost and timeline. Disadvantage of 5 years exclusivity only on launch which reduces terminal value - but that's reducing worth a lot, a lot to just a lot . They may get taken out half way through the clinical if they want a quick deal and someone really wants it. This is 1-2 year timeline.
I'm not a trader like you guys so I value all info financial knowledge. I am a pharma guy though so its worth reading their latest presentation on their website as its's telegraphing what they plan to do.
Slide 10 and 11 - obvious they plan to reformulate for controlled release. Several technologies can do this so its not hopeful thinking. Also sounds like their patents on this pre-date anybody else attempting this.
Slide 13. They are going 505B2 regulatory pathway. Less exclusivity (maybe 5 or so years and not the 11, 12 or 13 that you could get) but way cheaper phase 3 clinical. Now we talking in the single digit or low 10s of millions and not in the 100's of millions in costs. We are talking a year or two and not +3 years. They may still be able to wrap technology in other patents to get more exclusivity than this regardless.
Basically at these prices I'm in. This company may be worth nothing in a couple of years or a few hundred million. Worth the risk for me.
I keep buying this stock and it keeps going down. Their infrastructure is worth more than their company - never mind any IP. I have no idea why they don't just apply to the gov for support to make essential medicines - they at least could actually do it unlike Kodak who has minimal chance of pulling it off. They actually have real GMP manufacturing assets and an organization than could make generic pharma products and actually know how to do it - unlike several who haven't a clue.
I've been lurking in the comments section and reading these posts on RSPI for a while. I appreciate all the comments and info.