FDA identified certain technical deficiencies

Chelsea Therapeutics announces update to NORTHERA (Droxidopa) NDA Filing; FDA identified certain technical deficiencies (CHTP) : Co announced that the FDA, upon further review of the Company's resubmitted New Drug Application (NDA) for NORTHERA (droxidopa), has identified certain technical deficiencies in the resubmission that will require resolution prior to the resubmission being deemed a complete response. As previously announced on July 17, 2013, Chelsea had received written confirmation from the FDA that the resubmission was deemed to be a complete response to its March 28, 2012 Complete Response Letter and was assigned a new PDUFA date of January 3, 2014. However, the FDA has now notified the Company that they have noted deficiencies that relate primarily to the formatting of certain submitted electronic datasets and statistical programs describing the methods used to generate tables and listings. The deficiencies are unrelated to study conduct, interpretability of study results, or validity of study conclusions. The Company believes that the matter can be resolved quickly, and expects to submit the necessary response in August. Until the response is received by FDA, the Agency has informed Chelsea that the six month review clock for the NDA specified under the Prescription Drug User Fee Act (PDUFA) will not start. Therefore, upon a successful resubmission with the currently requested changes sought by the FDA, a new PDUFA date will be set by the Agency.

http://finance.yahoo.com/marketupdate/inplay#chtp

Chelsea Therapeutics pullback a buying opportunity, says Needham.
http://finance.yahoo.com/news/chelsea-therapeutics-pullback-buying-opportunity-123618734.html

That should be FCGD,sorry.EOM

As long as we keep closing above $3,
CHTP will be in good shape,IMO.
Welcome new buyers!!

FCDG - First Colombia Gold Corp.

Don't really care to play trips,but this one looks good for a quick 50% flip for next week. PPS .0009

http://stockcharts.com/h-sc/ui?s=FCGD

DRRX - Moving up,ready to break out.

http://stockcharts.com/h-sc/ui?s=DRRX

http://www.thestreet.com/story/11989566/2/5-stocks-under-10-set-to-soar.html

5 Stocks Under $10 Set to Soar

http://www.thestreet.com/story/11989566/2/5-stocks-under-10-set-to-soar.html

Go DRRX.

Very few shorts here,so no short squeeze on this one.
http://shortsqueeze.com/?symbol=drrx&submit=Short+Quote%99

CHTP - Short Interest (Shares Short) 6,443,100

131.78% increase. 12.71 % of the float.

http://shortsqueeze.com/?symbol=chtp&submit=Short+Quote%99

Keep the pressure on and squeeze them to $4.

OK,enough accumulation in the $3.10 area.

Time to move to $3.50 level and make a few more stubborn shorters suffer a little more pain for not covering here.
CHTP needs some more Big Boy money to start buying again.
100,000 share ask slaps are probably coming soon. Do it!

OWOO - Parabolic SAR Buy Signal

http://stockcharts.com/def/servlet/SC.scan?s=TSAL[t.t_eq_s]![as0,20,tv_gt_40000]![ap1,0.02,0.2_gt_tc1]![ap0,0.02,0.2_lt_tc0]&report=predefall

CHTP - Finally getting some respect.

Second wave of OWOO buying just starting

See .04 to .05 easily this week,IMO.GLTA

7 million float.We've already traded that many shares today.

New HOD just hit. Up over 100%.

$$OWOO$$ This could be a biggy.

Nice DD by TOUCAN.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=90119981
Heads up MM board!!

Love that weekly chart. 5-10 banger??

http://finance.yahoo.com/q/mh?s=CHTP+Major+Holders

OWOO One World Holdings, Inc. for Monday

http://www.otcmarkets.com/stock/OWOO/company-info

http://stockcharts.com/h-sc/ui?s=OWOO

http://investorshub.advfn.com/One-World-Holdings-Inc-OWOO-26126/

Not listed on P&D site:
http://www.pumpsanddumps.com/p/pumpsanddumpscom-hall-of-fame.html#uds-search-results

Have a great weekend everybody!!

CHTP 75% chance FDA approves Northera

Here we go again. Chelsea resubmitted Northera to FDA. This time, the approval filing includes data from another phase III study showing significant and meaningful reductions in dizziness and lightheadedness --- the FDA's preferred endpoint to measure clinical benefit in NOH patients. Chelsea still lacks data demonstrating durability of Northera's effect, but FDA appears willing to allow a post-approval trial to take care of this commitment.
FDA set Jan. 3, 2014 as the approval decision date for Northera. The agency also told Chelsea that it may bring the drug in front of a second advisory panel prior to making a final decision. The first panel voted in favor of Northera despite hairy data and an oppositional FDA. It's hard to envision a scenario under which a second panel -- presented with even more data confirming Northera benefit for NOH patients -- doesn't also vote to recommend approval.
I believe there's a 75% chance FDA approves Northera on the second go-around with Chelsea. The stock's current market value of less than $200 million does not fully account for the drug's approval and commercial market opportunity.

http://www.thestreet.com/story/11982642/3/biotech-stock-mailbag-sarepta-chelsea-ipo-fever.html

Looks pretty promising.

TCPS - Another wild one.Wow!

http://ih.advfn.com/p.php?pid=webchart&symbol=TCPS&period=0&size=19&volume=1

A stock with a STOP sign on it,too boot,go figure.
http://www.otcmarkets.com/stock/TCPS/quote
Thanks for the awareness post.

Looks like we're getting some attention today.

It appears we may make a new 52 week high($2.84) here shortly. Nice.
Let's see if we pick up a few fund buyers this afternoon or Monday. CHTP should be at least over $3 in value by this point. GLTU
Glad to see some other posters on this board,finally. LOL

Burn, baby, burn! http://shortsqueeze.com/?symbol=chtp&submit=Short+Quote%99

75% chance FDA approves Northera

Here we go again. Chelsea resubmitted Northera to FDA. This time, the approval filing includes data from another phase III study showing significant and meaningful reductions in dizziness and lightheadedness --- the FDA's preferred endpoint to measure clinical benefit in NOH patients. Chelsea still lacks data demonstrating durability of Northera's effect, but FDA appears willing to allow a post-approval trial to take care of this commitment.
FDA set Jan. 3, 2014 as the approval decision date for Northera. The agency also told Chelsea that it may bring the drug in front of a second advisory panel prior to making a final decision. The first panel voted in favor of Northera despite hairy data and an oppositional FDA. It's hard to envision a scenario under which a second panel -- presented with even more data confirming Northera benefit for NOH patients -- doesn't also vote to recommend approval.
I believe there's a 75% chance FDA approves Northera on the second go-around with Chelsea. The stock's current market value of less than $200 million does not fully account for the drug's approval and commercial market opportunity.

http://www.thestreet.com/story/11982642/3/biotech-stock-mailbag-sarepta-chelsea-ipo-fever.html

2 Biotech Stocks Under $10 to Watch

http://www.thestreet.com/story/11983215/3/2-biotech-stocks-under-10-to-watch.html

Good luck on your shareholder vote this morning.

CLSN - Should be a wild one Friday.

http://stockcharts.com/h-sc/ui?s=CLSN
Voting on a Reverse Split tomorrow. This would be for trading only so I would be very careful if you play.

Read the boards:
http://investorshub.advfn.com/boards/board.aspx?board_id=15825
http://finance.yahoo.com/mb/CLSN/

If anything there should be some heavy volume tomorrow and a lot of eyes(QoQ)watching this one.

Looks like short covering and back filling to $2.60 level is over for the day.Time to move back over 2.70 level again. I believe we have a lot of shorts in trouble in CHTP.

Short Interest (Shares Short)
2,779,800 Let's fry them!!
http://shortsqueeze.com/?symbol=chtp&submit=Short+Quote%99

Come on buyers squeeze them to over $3.00 in a couple days.

I see the Creamer is looking at DRRX.

4 Biotech Stocks Under $10 Making Big Moves
http://www.thestreet.com/story/11980290/1/4-biotech-stocks-under-10-making-big-moves.html?puc=yahoo&cm_ven=YAHOO

I wonder if he bought some? GLTA

Putting a BUY recommendation on DRRX

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=90030347

GLTA

CHTP - (CLOSES) at 52 week high $2.70 EOM

CHTP - Hitting 52 week highs currently
Looks like a strong close today.

http://stockcharts.com/h-sc/ui?s=CHTP

RAFA- Holy crap

http://stockcharts.com/h-sc/ui?s=RAFA

We're getting some good picks and awareness posts on this board.

CHTP,DRRX,MU,NOHO

DRRX - Durect Corp. looks good here,IMO


http://stockcharts.com/h-sc/ui?s=DRRX

Short term target:$1.60
Long term target: $3 to $4

Holding my CHTP pick;ride for the long haul now.

http://ih.advfn.com/p.php?pid=nmona&article=58446114&symbol=CHTP

http://stockcharts.com/h-sc/ui?s=CHTP

CHTP - Chelsea Therapeutics announces FDA acceptance of NORTHERA (droxidopa) NDA resubmission

Co announced that the FDA has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market NORTHERA (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The FDA has deemed the resubmission a complete response to its Mar 28, 2012 Complete Response Letter and assigned a new Prescription Drug User Fee Act (PDUFA) goal date of Jan 3, 2014.

Sentiment:Strong Buy
Long term target: $10 to $12,IMO

Market Pulse for CHTP

http://finance.yahoo.com/marketpulse/CHTP

$CHTP oh and the FDA has max 60 days to accept the NDA filing. If they say it will get accelerated review lookout -- we go north $5

CHTP Nice support level at $2.55

IMO,we'll close the week between $2.80 and $3.00.

http://stockcharts.com/h-sc/ui?s=CHTP

Long term target $10 to $12.

http://chelseatherapeutics.com/


Chelsea Therapeutics is committed to providing new medications that will improve patients’ quality of life.

Chelsea was founded in 2004 and has since transitioned into a public company. We have a late-stage product candidate for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) that leverages the company’s development expertise and accelerates the company’s drug commercialization efforts.

Chelsea is pursuing an orphan drug strategy for the development of Northera™ (droxidopa). The first indication we are pursuing for the drug is for the treatment of nOH in patients with primary autonomic failure (Parkinson’s disease, multiple systems atrophy, and pure autonomic failure), dopamine-ß-hydroxylase deficiency, and non-diabetic autonomic neuropathy.* Since acquiring the global development and commercialization rights to Northera™ in 2006 from Dainippon Sumitomo Pharma Co., Ltd., excluding Japan, Korea, China and Taiwan, Chelsea has conducted multiple clinical trials investigating the safety and efficacy of the drug. We are also evaluating the potential therapeutic applications of Northera™ in reducing the frequency of falls in patients with nOH associated with PD as well as other potentially norepinephrine-related conditions and diseases including intradialytic hypotension, fibromyalgia and adult attention deficit hyperactivity disorder.

In addition to Northera™, we have a portfolio of metabolically inert antifolates that we have studied as a potential treatment for rheumatoid arthritis. They also may be suitable for the treatment of multiple other autoimmune disorders.

*Northera™ is an investigational new drug not currently marketed in North America and the European Community. No claims on the safety and efficacy of Northera™ for the treatment of neurogenic orthostatic hypotension are being made, implied, or intended by the resources contained here within.

CHTP Nice support level at $2.55

IMO,we'll close the week between $2.80 and $3.00.

http://stockcharts.com/h-sc/ui?s=CHTP

Would have been nice to catch RAFA at the .10 to .15 level.I hope you do well and GLTU. Good call. What's your price target on this stock? TIA

CHTP Very good support at $2.40 currently.

Long term price target $10 to $12 on Northera approval,IMO.

http://www.zacks.com/stock/news/103615/northera-nda-resubmitted-by-chelsea

IGXT - Huge bids out there again.

People want in real bad, for some reason.
More than usual volume the last couple days.

http://www.otcmarkets.com/stock/IGXT/quote

Somebody wants to give their shares up @ .69

Eat 'em up boys.Great day here!Nice volume.
http://www.otcmarkets.com/stock/IGXT/quote
Go IGXT!
.69 are getting hit,currently.
Slap that ask and make them regret selling here.

I'm not sure if they've been covering them all.
They did PR this one from July 5 though.
http://online.wsj.com/article/PR-CO-20130705-905574.html

IGXT is looking good today.
http://www.otcmarkets.com/stock/IGXT/quote
The large bids have been coming in all day so far.Good sign.
Might see a little resistance at .70.Get past that and it's game on!!

The Wall Street Journal news department was not involved in the creation of this content.

http://online.wsj.com/article/PR-CO-20130709-905094.html?mod=googlenews_wsj

That's all I found.Same PR as yesterday.

IGXT

Nice bids out there this morning.
http://www.otcmarkets.com/stock/IGXT/quote
http://stockcharts.com/h-sc/ui?s=IGXT

IGXT - Large bids coming in

http://www.otcmarkets.com/stock/IGXT/quote
Volume is picking up on this stock now.
Above the 50 and 200 DMA now.
http://stockcharts.com/h-sc/ui?s=IGXT

IGXT -IntelGenx Technologies Corp.

http://www.otcmarkets.com/stock/IGXT/quote

http://stockcharts.com/h-sc/ui?s=IGXT

Have a feeling this one is ready to make it's move.Get in ahead of the herd. .60 is a good buy.

http://www.intelgenx.com/

CHTP news - InPlay

Chelsea Therapeutics resubmits new drug application for NORTHERA for the treatment of Symptomatic Nohutics (CHTP) 2.65 : Co announced that it resubmitted a New Drug Application to the FDA seeking approval to market NORTHERA, an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure. dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

The NDA resubmission includes data from Study 306B, a large phase 3 study which confirms findings from Study 301 demonstrating improvement in dizziness/lightheadedness, the cardinal symptom of NOH. Under the Prescription Drug User Fee Act, or PDUFA, the FDA is expected to review and act on the NDA six months from the date of resubmission.

In addition to Study 306B, the filing also includes three smaller supportive randomized controlled trials, two long-term open-label extension studies, a dedicated thorough QTc study, a 24-hour ambulatory blood pressure monitoring study and a bioequivalence study for the 300 mg dose form of droxidopa. The bioequivalence study showed comparable pharmacokinetics between the 300 mg dose form of droxidopa and the 100 mg and 200 mg combination dose form. Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.

http://finance.yahoo.com/marketupdate/inplay#chtp

http://stockcharts.com/h-sc/ui?s=CHTP

Big gapper in PPS today.