Chelsea Therapeutics International Ltd. (NASDAQ:CHTP)

more likely to drop than rise

It seems that once again the market is taking Chelsea in the wrong direction, enthusiastically bidding up the share price on news that the FDA has reversed itself and stated that study 306B has the potential to serve as the basis for a Northera NDA resubmission. Of course, there's a big difference between serving as the basis for an NDA submission and the basis for an NDA approval. And the market seems to have forgotten that the 306B topline data was actually pretty bad, with no evidence of statistically significant benefit beyond the first week of treatment.

The FDA has shocked me before, for example by reversing themselves and approving Vanda's Fanapt a few years ago. But in general I find it wiser to go with the FDA's usual approach to this type of weak NDA application rather than to bet on the black swan.

Bought today in RL at ~$1.50; looking for a possible multi-bagger and a quick mega jump.

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

next FDA meeting will get approved

Wait and watch

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

american pharma

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.

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.

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.

On October 1st the company announced that their Phase III trials of Droxidopa show significant benefits in the treatment of neurogenic orthostatic hypotension. Stock price was up 20% on a day that the S&P 500 was down 2.58%. Recently there has been significant insider purchasing by one 10% owner which increased his holding by 12%. One analyst has set his price target at 3 times the current price. To quote Freddie Prinze from the 1970’s …“Looking good!”

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CH1504 is not a real new drug, chtp just improves it by replacing the acid component which causes some side-effects. The risk is low in getting rejection from FDA. If and when approved CHTP is a $50 stock.

Trending down.