Chelsea Therapeutics International Ltd. (NASDAQ:CHTP)

CAPS Rating: 1 out of 5

A development stage pharmaceutical company that seeks to acquire and develop innovative products for the treatment of a variety of human diseases.

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Member Avatar palm91 (25.19) Submitted: 3/3/2014 6:44:39 PM : Outperform Start Price: $5.64 CHTP Score: -15.94

likely candidate for buy out, orphan drug

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Member Avatar drunknmonkey213 (< 20) Submitted: 2/25/2014 10:30:45 PM : Outperform Start Price: $5.67 CHTP Score: -17.20

After it's main drug Northera was approved mid-February, the stock jumped higher, though only to a similar high as when an FDA advisory panel voted overwhelmingly to approve Northera one month earlier (over $6 after-hours). Shorts and critics believe the FDA-required post-approval trials will be too costly to merit investment, and that the company will need to either partner up for marketing and distribution, to dilute with new shares to raise capital for the product's launch, or to sell entirely to a larger company in order to move forward. I believe the ability to begin selling and distributing the product in the U.S. (likely starting full-scale mid-2014) will immediately drive revenue massively higher and that the talented management in place will be able to properly manage funds and select the appropriate route for the company. Taking a look at the three aforementioned options: A sale of the company before a new stock offering would have to come at a premium to the current price; a partnership for distribution would obviously reduce distribution costs, increase revenue from its current levels, and allow for increased funds for future development and expansion of the product into Europe where it is currently under review; and the company's likely move to market and distribute the product itself, if run properly, could maximize long term revenue, and maintain total rights to the profits from sales of the product in the United States. The third option quite possibly would require the company to issue new shares to fund the product's launch, in which case I would be buying heavily given the worth of the FDA approved product, regardless of any management skill or decision-making ability. All the aforementioned, and the product's possibility to reduce falls and provide other advantages to patients still to be proven statistically, leave the drug with extreme upside in numerous realms now that the FDA has approved it, pending future studies.

Shorts would also highlight Northera's only considerable competing drug in its area from Shire is set to release results from its required post-approval studies for its drug. While positive results of the study could of course have a detrimental effect to Northera and Chelsea as a whole, that effect is much overrated as that drug has already been approved for use. A more bearing effect would be if negative results were revealed to taint Shire's product, which would reduce Chelsea's already minimal competition.

While there is much left this year for Chelsea's launch of Northera and the company's future has many possibilities, the current price reflects a company still struggling to gain footing in the biopharma industry, rather than a company with an FDA-approved drug for a decent-sized population of patients who could benefit from the drug in its current state with few side effects, and who could reap future benefit from different doses of the drug to last for a longer duration or from the current dosage for reduction of other symptoms. The short percentage in the stock has increased greatly since the drug's approval, and any partnership or proven distributorship should lead to massive growth organically and stock appreciation through growth and short squeeze from its current price level.

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Member Avatar larssral (53.66) Submitted: 2/19/2014 7:00:53 PM : Underperform Start Price: $6.10 CHTP Score: +24.16

this is definitely the kind of pharma stock that will underperform post-approval. there's a clear need out there, but it's a very small population. and they're going to need to dilute. and once they start back into developing their stalled pipeline they're going to be spending a nice bit of cash while trying to turn an initial profit. i suspect this will be back down into the high 4s rather soon.

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Member Avatar HIGHG33K (73.71) Submitted: 2/4/2014 12:21:59 AM : Outperform Start Price: $4.34 CHTP Score: +2.45

FDA will thumbs up

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Member Avatar manirg (41.06) Submitted: 1/15/2014 3:34:45 PM : Outperform Start Price: $4.45 CHTP Score: +5.39

Very under valued with respect to its sales potential

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Member Avatar genedom (98.75) Submitted: 1/8/2014 12:54:07 AM : Outperform Start Price: $3.30 CHTP Score: +41.73

FDA will approve this time

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Member Avatar khamtheman (34.19) Submitted: 11/19/2013 12:20:43 AM : Outperform Start Price: $3.31 CHTP Score: +38.96

FDA WILL APPROVE ON 2/14/14

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Member Avatar SmartAce (99.82) Submitted: 10/25/2013 12:54:02 PM : Underperform Start Price: $2.95 CHTP Score: -53.40

short

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Member Avatar ptanabe (52.82) Submitted: 7/31/2013 6:46:11 PM : Outperform Start Price: $2.98 CHTP Score: +49.08

k

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Member Avatar new2fool23 (34.28) Submitted: 7/19/2013 1:52:53 PM : Outperform Start Price: $2.76 CHTP Score: +60.97

Just gonna watch this one.

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Member Avatar zzlangerhans (99.73) Submitted: 6/7/2013 1:20:54 AM : Underperform Start Price: $2.22 CHTP Score: -97.59

The Northera soap opera continues as Chelsea plans to resubmit the NDA in late Q2 or early Q3, and the stock is rising presumably on the basis of Chelsea's position that they will be allowed to perform a confirmatory phase III trial subsequent to approval. Aside from the fact that I can't remember any drugs from small cap biopharmas being approved ahead of a confirmatory efficacy trial in the last seven years, the current efficacy data is both weak and conflicting. While Chelsea isn't out for the count I'd hardly be declaring victory at this point, and I'd be looking for at least one fairly large secondary before the next PDUFA.

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Member Avatar awosha1 (59.23) Submitted: 12/17/2012 8:39:16 PM : Outperform Start Price: $0.89 CHTP Score: +402.02

A marginal drug with only one marginal competitor in the space stillhas lots of hope.

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Member Avatar mekadik (< 20) Submitted: 7/22/2012 3:01:54 PM : Outperform Start Price: $1.08 CHTP Score: +299.35

next FDA meeting will get approved

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Member Avatar measured (71.81) Submitted: 4/24/2012 4:48:17 PM : Outperform Start Price: $2.06 CHTP Score: +95.18

Wait and watch

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Member Avatar RBuskey106 (63.41) Submitted: 4/2/2012 5:35:24 PM : Outperform Start Price: $2.34 CHTP Score: +70.54

Chart play

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Member Avatar Zonata3 (52.36) Submitted: 2/14/2012 9:10:28 AM : Outperform Start Price: $3.26 CHTP Score: +7.03

Beaten down for a simple matter... will get back on its feet in few day (target 5,50$)

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Member Avatar KimLanners (< 20) Submitted: 4/18/2011 11:12:20 AM : Outperform Start Price: $4.83 CHTP Score: -45.75

american pharma

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Member Avatar bg019818 (< 20) Submitted: 12/30/2010 7:34:43 PM : Outperform Start Price: $7.59 CHTP Score: -86.16

The latest trial studies have proven successful. Plus this drug has been put on the "fast track" in order to get it to market faster.

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Member Avatar daddycswhite (45.76) Submitted: 10/4/2010 1:56:11 AM : Outperform Start Price: $5.47 CHTP Score: -76.50

CHTP's been a darling of mine for about a year; We've seen the initial jump due to the successful NOH results of Droxidopa's recent phase III result RETEST.

A 35 Million dollar share offering at below market on friday was fully subscribed; following what has been an absolutely incredible showing of institutional support for this stock since April.

Chelsea has management of all ex big pharma who left nearly simultaneously to form CHTP. The failed initial NOH was due to a miscalculated endpoint that was subsequently corrected.

What has happened in the meantime is extraordinary; it has been proven without doubt that patients participating in the clinical trials suffering from ADHD AND FIBROMYALGIA, two enormous markets, experienced near total elimination of symptoms...an unbelievable development that one recent article referred to as the potential "blockbuster drug we all dream of". The FDA agreed to such a strong degree they granted Chelsea fasttrack status to both, and now we await the phase II results, whose initial indications point to unbridled success; if true, the potential revenues for this drug are nearly impossible to quantify; several have guessed at PPS's from thirty to eighty and more.

An early indication that this was a slam dunk; the venture capitalist, Venrock, behind a recent (Feb?) revenue deal accepted AT PAR stock...and Venrock isn't dim money; they're all ex Goldman. The fully subscribed sale at 4.90 this past friday saw a volume spike of incredible proportions, and a stock rise as well.

This is a company whose upside is so great it is hard to fathom; but remember this; there has not been an insider sale of this company's stock in over two years. Not one. Institutions, since April, have supported it nearly five to one in buyers to sellers...

Management, liquidity, solid product, incredible upside (they have near global rights), insider and institutional support, and the buy in by perhaps one of the best VCs in the area...

Find me a reason not to love it.

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Member Avatar connorsdad418 (< 20) Submitted: 3/20/2010 3:53:53 PM : Outperform Start Price: $3.79 CHTP Score: -36.84

insane upside for Droxidopa, a drug already approved and in therapeutic use in Japan for 17 years. CHTP has all global rights to this drug excluding Japan, China, Korea and Taiwan.
The NOH therapeutic benefit (as per Japan) is in the final stages of a phase III clinical trial. therapeutic benefits for ADHD and Fibromyalgia and Alzheimers...yes, those are all legit...are founded, to the point two of them (ADHD AND FIBRO) are in phase II clinical trials. The company is all ex big Pharma from Roche, is heavily invested in it's own product (zero insider sales in 2 years), and is incredibly valued at a total market cap of a mere 127 Million. For a company with a drug with Droxidopa's approval likelihood and potential upside, this is the most likely multibagger I have personally ever seen.

hop on...it'll head to seven/ten, then if the phase II trials advance to 20-30...and up from there should those ever pan out.

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