Transdel Pharmaceuticals, Inc. (TDLP)

[colorofmoney]

TDLP News..Transdel Pharmaceuticals Reports Excellent Results of Initial Testing on
Anti-Cellulite Product Conducted by JH Direct

LA JOLLA, Calif., Sept 09, 2010 /PRNewswire via COMTEX/ -- Transdel
Pharmaceuticals, Inc. (TDLP) ("Transdel") reported today that JH Direct has
completed their initial product testing of Transdel's anti-cellulite formulation
in 24 subjects, which consisted of observing the before and after results of
applying the product over a 16 week period. The excellent results observed during
this test have led JH Direct to initiate plans for a final test in approximately
25 subjects to be conducted by a third-party skin research center that will
conduct a similar test to the initial test as well as obtain additional
measurements over a 12 week period. JH Direct is planning a commercial launch of
the product for the fourth quarter of 2010 or in early 2011 subject to successful
completion of this final test.

Under the terms of its exclusive worldwide licensing agreement, JH Direct will
pay Transdel initial royalty advances and a continuing licensing royalty on the
worldwide sales of the anti-cellulite product. The product will be initially
launched through a direct response television campaign created and managed by JH
Direct, followed by a planned expansion into traditional channels of
distribution, such as retail and wholesale channels.

"We are pleased with JH Direct's product development progress and
commercialization plans for our anti-cellulite product; given their significant
experience and past success with direct response television campaigns we are
confident they will maximize the potential of our product," stated John Lomoro,
Acting Chief Executive Officer and Chief Financial Officer. "The eventual launch
of this product will be a significant milestone for Transdel."

"We are very pleased with the results that the participants experienced from our
initial testing and are excited to be moving into the final testing phase for the
anti-cellulite product," stated Johann Verheem, JH Direct's Chief Executive
Officer. "We believe there is a large market opportunity for an anti-cellulite
product that works as well as this product has proven in our initial testing and
we are looking forward to introducing this product to the market."

About Transdel Pharmaceuticals, Inc.

Transdel Pharmaceuticals, Inc. (TDLP) is a specialty pharmaceutical company
developing non-invasive, topically delivered products. The Company's
innovative-patented Transdel(TM) cream formulation technology is designed to
facilitate the effective penetration of a variety of products through the tough
skin barrier. Ketotransdel(R), the Company's lead pain product, has completed a
Phase 3 clinical trial and utilizes the Transdel(TM) technology to deliver the
active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin
directly into the underlying tissues where the drug exerts its well-known
anti-inflammatory and analgesic effects. The Company intends to leverage its
Transdel(TM) platform technology to expand and create a portfolio of topical
products for a variety of indications. The Company is actively pursuing
partnerships with companies to expand its product portfolio for pharmaceutical
and cosmetic/cosmeceutical products. For more information, please visit
http://www.transdelpharma.com.

About JH Direct, LLC

JH Direct, LLC is a fully integrated Direct Response Television Company focusing
on developing sustainable brands launched through direct response television
campaigns as part of a multi-channel distribution approach. The JH Direct senior
management team has created and managed some of the most successful Direct
Response Television brands in the cosmeceutical, beauty and fitness categories
since the mid nineties.

JH Direct is funded by JH Partners, a San Francisco-based private equity firm
focused on building sustainable, long-term equity value in consumer and
marketing-driven growth companies. http://www.jhpartners.com

Safe Harbor Statement

The Company cautions you that the statements included in this press release that
are not a description of historical facts are forward-looking statements. These
include statements regarding: the Company's interpretation of the results of the
initial testing of its anti-cellulite product; the results of the final tests of
its anti-cellulite product and JH Direct's plans to commercially launch the
anti-cellulite product. Actual results may differ materially from those set forth
in this press release due to the risks and uncertainties inherent in the
Company's business, including, without limitation: the outcome of the final tests
on the Company's anti-cellulite product may not be favorable, the timing of JH
Direct's commercial launch of the anti-cellulite product may be delayed, JH
Direct's efforts to commercially launch the anti-cellulite product may not be
successful, the Company may receive limited licensing proceeds, and the Company
may be unable to secure sufficient funding to complete its product development
plans. More detailed information about the Company and the risk factors that may
affect the realization of forward-looking statements is set forth in the
Company's filings with the Securities and Exchange Commission, including its
Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the
SEC. Such documents may be read free of charge on the SEC's web site at
http://www.sec.gov. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this cautionary
statement and the Company undertakes no obligation to revise or update this press
release to reflect events or circumstances after the date hereof. This caution is
made under the safe harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995.

SOURCE Transdel Pharmaceuticals, Inc.

Copyright (C) 2010 PR Newswire. All rights reserved

[colorofmoney]

This stock has been under radar.

[colorofmoney]

This huge news

[colorofmoney]

TDLP Alert...Anti-inflammatory drug delivered through skin set to net $10 million upfront deal
Written by M.E.Garza
Thursday, 22 July 2010 16:07
1diggdigg

As we told our subscribers on Thursday morning, this company's innovative-patented cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier.

In essence it is a topical cream delivery system that is among the most elegant and effective and now, sources are telling us that there is a significant event on the horizon which could impact share prices significantly, especially given the size of the tightly held share float.

The company is Transdel Pharmaceuticals Inc (OTC: TDLP) and it has a product called Ketotransdel® which is Ketoprofen in their delivery system.

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAIDs).

Prescription ketoprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints).

Nonprescription ketoprofen is used to relieve minor aches and pain from headaches, menstrual periods, toothaches, the common cold, muscle aches, and backaches. Ketoprofen works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Ketotransdel®, the Company's lead late stage pain product, utilizes the Transdel™ technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug (“NSAID”), through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects.

We do know that the market for NSAIDs delivered transdermally has been growing rapidly and that there are two competitive products from King Pharma- the flector patch which is a patch of Volataren (Diclofenac) and one by the old Ciba company which is a gel.

Ketoprofen is a more effective product when dermally delivered and their system allows 10x more drug to be used.

The prior two products have grown to over $300 million in three years and the market is estimated at over $4.5 billion in the US alone.

Transdel had good Phase 3 results but as typical with pain products, they find themselves in a position in which they need to duplicate those Phase 3 trials.

Sources tell us it will cost $7 mill and take at least 1 year, but already the company has been negotiating with several pharmaceutical companies, including a good sized private one and several big international ones.

Those same industry sources indicate that Transdel is very close to a deal with one or two companies that could mean a $10 million upfront cash deal as well as the expenses for the trial being paid for by the partner. In addition, there are indications that the company could recieve a royalty payment in excess of 25%.

Interestingly, on the company's own website, they indicate that they are seeking a commercial partner for Ketotransdel®, and are actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.

Industry sources are telling us that they are expecting this news sometime in the next 10-20 days. In the meantime, we fully expect to reach out to company officials for more informaiton and/or an interview in hopes of learning more details as we chase this story.

Disclosure: No Positions

[colorofmoney]

Data from Transdel Pharmaceuticals' Phase 3 Study to be Presented at 13th World Congress on Pain
prnewswire

Press Release Source: Transdel Pharmaceuticals, Inc. On Tuesday May 4, 2010, 8:00 am

LA JOLLA, Calif., May 4 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board:TDLP.ob - News), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced that its abstract entitled "Efficacy And Safety Of Ketoprofen 10% Cream In The Treatment Of Pain Associated With Acute Soft Tissue Injuries (Phase 3 Study TDLP-110-001)" was accepted for presentation at the 13th World Congress on Pain to be held August 29 to September 2, 2010 in Montreal, Canada. The poster is to be presented by lead author Dr. Evan Ekman, President of Southern Orthopaedic Sports Medicine in Columbia, SC.

"The upcoming presentation of our data at the world's premier congress devoted to research and treatment of pain is a significant event for our company," said Transdel's Chief Medical Officer, Dr. Joachim Schupp. "We look forward to sharing the full Phase 3 clinical data as it will provide additional insight into the efficacy and safety of Ketotransdel®."

The World Congress on Pain is organized every two years and attracts thousands of the world's leading experts on pain to share their thoughts, research and findings on this critical topic.

About Transdel Pharmaceuticals, Inc.

Transdel Pharmaceuticals, Inc. (OTCBB:TDLP.ob - News) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel™ cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead pain product, utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel™ platform technology to expand and create a portfolio of topical products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. For more information, please visit http://www.transdelpharma.com.

Forward-Looking Statements

The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the Company's interpretation of the results of its Phase 3 clinical trial for Ketotransdel®; whether the results from the clinical trial, along with any other clinical trials that may be required by the FDA, will be sufficient to support a 505(b)2 New Drug Approval (NDA) submission; the potential indications for use for Ketotransdel®; the market opportunity for the Company's products; and the Company's ability to complete additional development activities for products utilizing its proprietary transdermal delivery platform. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the outcome of the final analyses of the data from the Phase 3 clinical trial may vary from the Company's initial conclusions; the FDA may not agree with the Company's interpretation of such results or may challenge the adequacy of the Company's clinical trial design or the execution of the clinical trial; the FDA may continue to require the Company to complete additional clinical trials for Ketotransdel® before the Company can submit a 505(b)2 NDA application; the results of any future clinical trials may not be favorable and the Company may never receive regulatory approval for Ketotransdel®; the third parties upon whom the Company relies to conduct its clinical trials may not perform as expected; technological changes or competitive products or pricing may prevent the Company from successfully commercializing its products; and the Company's current need to raise additional funding to complete its product development plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

[colorofmoney]

New Data..Time to wake up this potential beast!
- Current report filing (8-K)

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): January 27, 2010
TRANSDEL PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)

Delaware
(State of Incorporation) 000-52998
(Commission File Number) 45-0567010
(I.R.S. Employer Identification No.)

4225 Executive Square, Suite 485, La Jolla, California
(Address of Principal Executive Offices) 92037
(Zip Code)
Registrant’s telephone number, including area code: [phone]
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 8.01. Other Events.
Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, provides an update on the Phase 3 clinical study results with its lead pain drug Ketotransdel ® . Ketotransdel ® is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company’s innovative proprietary Transdel™ drug delivery system.
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States. The primary efficacy endpoint was the difference between Ketotransdel ® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on the Day 3 visit.
The Company has recently completed an in-depth analysis of the Ketotransdel ® Phase 3 study data and found that Ketotransdel ® demonstrated a statistically significant higher reduction in pain intensity than placebo in the Intent-To Treat- Analysis (ITT) of patients who met study entry criteria (p< 0.05). In addition, relevant other key endpoint analyses of the ITT population such as Pain Curves over Time show consistent separation between treatment groups reaching statistical significance in favor of Ketotransdel ® . Details are expected to be presented at a pain conference during 2010. This information is the result of detailed analysis of data that was not available at the time the top-line data were announced in October 2009.
As previously reported, the study achieved statistical significance in its primary endpoint in the per protocol analysis. Ketotransdel ® also demonstrated an excellent safety and tolerability profile. In particular, there were no Ketotransdel ® treatment related gastrointestinal, cardiovascular, hepatic or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.
Ketotransdel ® was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent blood sampling for pharmacokinetic (PK) analyses following repeated topical applications. These PK results are consistent with the Company’s previous clinical study findings and support the excellent safety profile.
Transdel continues to work with the FDA to meet the requirement for two adequate and well controlled Phase 3 clinical trials in order to obtain regulatory approval to market Ketotransdel ® .
The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel ® , and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.

SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: January 27, 2010

TRANSDEL PHARMACEUTICALS, INC.

By: /s/ Juliet Singh
Juliet Singh, Ph.D.
President & Chief Executive Officer

[DewDiligence]

Feuerstein’s comments are essentially a carbon copy of #msg-42212740. Feuerstein has been around the block a few times and has seen these kinds of disingenuous press releases enough times to detect the BS.

[Camaro1093]

New article on TDLP from Adam F... Seems like every stock I follow he bashes, lol.

http://www.thestreet.com/_yahoo/story/10609273/1/biotech-mailbag-transdel-pharma.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

JMO.
GLTA!

[io_io]

<" if they had listened to what I was saying ">

As usual, you come here Dew to MOCK the poor TDLP holders!

But you and friends should have listened to me when IDIX published it's SCAM data a while back - you were glowing, even claiming your "prediction" came true....lol: http://investorshub.advfn.com/boards/read_msg.asp?message_id=20377556

But not me, with an efficacy p-value of 0.81 (not a typo) I saw the BS: http://investorshub.advfn.com/boards/read_msg.asp?message_id=20384763
Then I noticed that the in fact the AEs DID reach statistical significance: http://investorshub.advfn.com/boards/read_msg.asp?message_id=20397711

But you ignored me, and pumped away: http://investorshub.advfn.com/boards/read_msg.asp?message_id=21027906 and http://investorshub.advfn.com/boards/read_msg.asp?message_id=21086834

Well a couple of days later, the FDA saw what I saw, and halted the HCV program, game over.
http://ir.idenix.com/phoenix.zhtml?c=131556&p=irol-newsArticle&ID=1025874&highlight=

Catastrophe, it lost 75% over a month while you PUMPED it, despite my posts !!!!

[DewDiligence]

…before you go on touting that TDLP is a scam…

Please don’t put words in my mouth. I did not say TDLP was a scam; however, their press release yesterday was disingenuous. I stand by what I asserted in #msg-42213070, which was posted yesterday morning while other posters on this board were celebrating the apparently bullish pre-market trading:

Those headlines are pure spin. The primary endpoint was clearly missed, and the data are almost certainly insufficient for FDA approval.

Look for management to continue spinning on the CC that starts in an hour. The spin may work initially, but investors will soon catch on.

Well, that’s pretty much the way things turned out. I feel sorry for the investor who bought shares yesterday at $4. They would not have paid that much if they had listened to what I was saying. Regards, Dew

[Camaro1093]

TDLP close @ $2!

GLTA!

[DewDiligence]

You can hear a pin drop around here today. What happened to all that “positive data” you guys were touting yesterday?

LMAO

[Camaro1093]

Maybe they'll move up after they release the detailed data (if it's positive)?

GLTA.

[rstar]

will be worth a second listen to the cc.
especially the later question about their communications w the fda.
though DD can be a bit of a douche he does know a lot abt the process
and the ceo specifically addressed what he brought up.
saying how fda is aware of compliance to protocol issues that left their one itt endpoint low... and was involved in design of the study...
also how they are not yet releasing the specifics of the study to do so at upcoming conferences...

[K from Cal]

Howe hard is it picking market leaders in industries. Let's see how about PG, MSFT, CSCO... Call me a genius.

I think Due even had DNDN as a biotech scam at one point if I remember correctly. I don't pay any attention to what he says, especially when he comes onto a board and starts bashing a stock he was never involved in. That's just spending too much time on non Due Diligence matters, which is stupid. Like I'm doing now and not going to do anymore of. I'm done with this topic.

[Camaro1093]

I'm still up ~70% here...

I think Dew believes almost every R&D Biotech is a scam... I wonder what he'll say if HEB eventually gets FDA approval...

JMO.
GLTA!

[K from Cal]

I don't see you picking any winners lately on your own. I'm up 40% on this stock. What did you pick today that was up so much? ZENG? lol!

I see you love Abbot, Pfizer, Johnson and Johnson. Now that takes some real intelligence to pick those and have the HUEVOS to put them as your terrific picks. Get real.

[Camaro1093]

Yeah. I was thinking volume would be at least 1M today... Maybe the big money will find out tomorrow...

GLTA.

[K from Cal]

imo, Look for second launch once big money discovers. Volume still very low.

[Camaro1093]

I agree. Partnering deal could be huge for TDLP, imo.

JMO.
GLTA!!!

[seabreezing]

Christmas a little early here. WOW!

[Camaro1093]

Great news! Thanks for the updates.

[rstar]

3.40 x 3.50

[rstar]

ceo clarified that fda very involved in design of phase 3 trials....

fda aware of challenges in trials and recognizes them (itt)

ppa is the most important

she stresses fda fully aware of itt type issues...

[Camaro1093]

I agree.

GLTA!

[rstar]

sounds like they are working closely w the fda every step of the way....

especially given the gastrointestinal health issues of oral pain meds...such a need
and likely they will find a big pharma partner

[Camaro1093]

CC in about 9 minutes... To participate in the call, dial 888-695-0608, or outside of the U.S., dial 719-457-2615, confirmation code 4282348 shortly before 9:00 am, eastern. The audio webcast can be accessed via the Internet by visiting the Investor Relations section of the Company's Web site at http://www.transdelpharma.com.

[Camaro1093]

2.75 BID x 3.00 ASK!

Congrats Longs!

GLTA!

[rstar]

2.75 x 3.00

[righty]

Why did you edit out the information about the ITT population?

yknow...the part that followed

"the Intent-to-Treat (ITT) population of the primary efficacy endpoint"

Why would you edit that out?

that in and of itself is somewhat suspicious

here is what the real pr said

"Analysis of the Intent-to-Treat (ITT) population of the primary efficacy endpoint (which includes all study patients even if they failed to comply with the protocol and study requirements) favored Ketotransdel® compared to placebo but not to a degree that reached statistical significance. "

(you then edited out portions of the following important official news release content and submitted your own bla bla bla comments????????? BY WHAT AUTHORITY????

"and We believe that this finding was not due to a lack of effect of Ketotransdel®, but rather due to patient compliance issues, non-adherence to protocol procedures and other potentially confounding factors (e.g., incorrect use of study drugs and/or concomitant use of unallowed drugs).
"

are you aware of what ITT population consists of? i think so otherwise there would have been no need to edit that important data out of the press release...i mena who in their right mind edit's out info from a pr in the first place??????? if the point trying to be made is valid no editing is required

are you even clued in to the INSIGNIFICANCE OF THIS DATA????

WAIT A SECOND

READ THIS PART AGAIN

"but rather due to

patient compliance issues,

non-adherence to protocol procedures and other potentially confounding factors

(e.g., incorrect use of study drugs

and/or concomitant use of unallowed drugs). ???????"


YOU ARE AWARE of why these factors make this data less than appreciable right?????

friggen amazing!!!!!!!!!!!!!!

AND FOR THAT YOU ARE DEEMING THE PRIMARY HAS FAILED???????

FAILED???????

LMAO......WHAT A JOKE!!!!!!!

[K from Cal]

Dew, Glass half empty for you? Guess you missed out on the buys. Don't be spiteful, just let us enjoy our victory. Maybe next time.

Plenty of great news here. An untapped market.

"Based on these positive top-line clinical results and the excellent safety
profile demonstrated, we believe Ketotransdel(R) is well-positioned to address a
critical need in the pain management marketplace. We are committed to continue
working closely with the FDA to bring this much needed drug to the marketplace as
soon as possible," stated Dr. Juliet Singh, President and Chief Executive Officer
of Transdel Pharmaceuticals. "In addition, this clinical study further validates
the great potential of our proprietary transdermal drug delivery platform, and we
look forward to maximizing the medical and commercial potential of this
technology to bring important therapies to patients."

[DewDiligence]

Those headlines are pure spin. The primary endpoint was clearly missed, and the data are almost certainly insufficient for FDA approval.

Look for management to continue spinning on the CC that starts in an hour. The spin may work initially, but investors will soon catch on.

[rstar]

Transdel Pharmaceuticals Announces Positive Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)

-- Primary Efficacy Endpoint Met
-- Excellent Safety and Tolerability Profile Demonstrated
-- Minimal Systemic Exposure Found in Pharmacokinetic Sub-Study
-- Company to Host Conference Call/Webcast Today at 9:00 a.m., (EDT)

[DewDiligence]

Sorry to break the news, but the phase-3 trial failed:

#msg-42212740

[rstar]

"There is a significant need among healthcare providers and patients for safe and effective therapies for pain management," said lead clinical investigator Evan F. Ekman, M.D. and President of Southern Orthopaedic Sports Medicine and Medical Director of Palmetto Health Parkridge Surgery Center. "The results from this Phase 3 clinical trial are very encouraging. They confirm to me that Ketotransdel® has a valuable role as a potentially safer and effective analgesic and anti-inflammatory treatment compared to available oral pain drugs, including oral NSAIDs, which are associated with gastrointestinal, cardiovascular and other medical problems."

[rstar]

huge news! that transdel could replace many applications of oral NSAIDs
that's aspirin and ibuprofen right?
pretty big market!!!!

[BioSpecialist]

POSITIVEEEE DATAAAA WOHOOOOO

Transdel Pharmaceuticals Announces Positive Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)

-- Primary Efficacy Endpoint Met
-- Excellent Safety and Tolerability Profile Demonstrated
-- Minimal Systemic Exposure Found in Pharmacokinetic Sub-Study
-- Company to Host Conference Call/Webcast Today at 9:00 a.m., (EDT)

Companies:Transdel Pharmaceuticals, Inc.
LA JOLLA, Calif., Oct. 6 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced positive top-line clinical results for its lead pain drug Ketotransdel®( )in a Phase 3 trial which evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities. Ketotransdel(®) is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company's innovative proprietary Transdel(TM) drug delivery system.


The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States.

The primary efficacy endpoint was the difference between Ketotransdel® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on Day 3. The VAS is a well known and validated instrument for pain measurement. The study achieved statistical significance in its primary endpoint in the per protocol analysis. The statistical analysis of those patients that complied with the study requirements (the per protocol (PP) population) included a total of 252 patients and showed a positive and statistically significant outcome in the primary efficacy endpoint between Ketotransdel® and placebo, reaching a p-value of less than 0.05.

Secondary endpoints included safety assessments and other efficacy parameters.

Ketotransdel® demonstrated an excellent safety and tolerability profile similar to the placebo cream. In particular, there were no Ketotransdel® treatment related gastrointestinal, cardiovascular or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.

Ketotransdel® was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent pharmacokinetic (PK) assessments following multiple exposures during the study. These PK results are consistent with the Company's previous clinical study findings.

Analysis of the Intent-to-Treat (ITT) population of the primary efficacy endpoint (which includes all study patients even if they failed to comply with the protocol and study requirements) favored Ketotransdel® compared to placebo but not to a degree that reached statistical significance. We believe that this finding was not due to a lack of effect of Ketotransdel®, but rather due to patient compliance issues, non-adherence to protocol procedures and other potentially confounding factors (e.g., incorrect use of study drugs and/or concomitant use of unallowed drugs).

"Based on these positive top-line clinical results and the excellent safety profile demonstrated, we believe Ketotransdel® is well-positioned to address a critical need in the pain management marketplace. We are committed to continue working closely with the FDA to bring this much needed drug to the marketplace as soon as possible," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "In addition, this clinical study further validates the great potential of our proprietary transdermal drug delivery platform, and we look forward to maximizing the medical and commercial potential of this technology to bring important therapies to patients."

"There is a significant need among healthcare providers and patients for safe and effective therapies for pain management," said lead clinical investigator Evan F. Ekman, M.D. and President of Southern Orthopaedic Sports Medicine and Medical Director of Palmetto Health Parkridge Surgery Center. "The results from this Phase 3 clinical trial are very encouraging. They confirm to me that Ketotransdel® has a valuable role as a potentially safer and effective analgesic and anti-inflammatory treatment compared to available oral pain drugs, including oral NSAIDs, which are associated with gastrointestinal, cardiovascular and other medical problems."

Further detailed analyses are currently ongoing, and the Company intends to present the clinical trial results at upcoming medical conferences and in peer-reviewed journals.

The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel®, and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.

[rstar]

going to be getting lot busier around here tomorrow i hope!

[Camaro1093]

Looking great today!

GLTA!

[eom7]

Looks like some one already has the news. Hope your right!

[BioSpecialist]

RALLLLLYYYYYYYYYYYYYY

TDLP WILL OPEN AT 5$+++ TOMORROW

GOOD LUCK ALL

[eom7]

In for that!

[BioSpecialist]

phase 3 data tomorrow

POSITIVE DATA = 6$++

Transdel Pharma (TDLP.OB)

MarketCap: 26 M$
Price: 1.67 $

Shares Out : 15,6 Mio

"Completion of enrollment for the pivotal Phase 3 clinical study is a significant milestone in the development program for Ketotransdel," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "We look forward to reporting the top-line results later this quarter, as previously announced."

Transdel Pharmaceuticals is seeking a partner for Ketotransdel and is either in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.


"Based on industry estimates, the market for NSAIDs and Cox-2 inhibitors exceeds $6 billion per year; more than 30 million people worldwide use NSAIDs daily. Due to the recognition of known risks associated with orally administered NSAIDs, including cardiovascular, gastrointestinal and other medical complications, and the decline in the use of Cox-2 inhibitors because of safety concerns, Transdel believes that there is a significant demand for topical pain management products such as Ketotransdel."

[colorofmoney]

Transdel Pharmaceuticals to Host Conference Call and Webcast on Tuesday, October 6, 2009 to Announce Top-Line Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)

* Press Release
* Source: Transdel Pharmaceuticals, Inc.
* On Monday October 5, 2009, 7:58 am EDT

Companies:
o Transdel Pharmaceuticals, Inc.

LA JOLLA, Calif., Oct. 5 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News) today announced that it will host a conference call and audio webcast on Tuesday, October 6, 2009 at 9:00 am, eastern, to announce the top-line results of its Phase 3 clinical study for Ketotransdel®, a topical cream based non-steroidal anti-inflammatory drug ("NSAID") for acute pain. A press release will be issued on Tuesday, October 6, 2009 at 7:30 am, eastern.
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Symbol Price Change
TDLP.OB 1.45 0.00
To participate in the call, dial 888-695-0608, or outside of the U.S., dial 719-457-2615, confirmation code 4282348 shortly before 9:00 am, eastern. The audio webcast can be accessed via the Internet by visiting the Investor Relations section of the Company's Web site at http://www.transdelpharma.com.

About Transdel Pharmaceuticals, Inc.

Transdel Pharmaceuticals, Inc. (OTCBB: TDLP - News) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel(TM) cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead pain product, utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel(TM) platform technology to expand and create a portfolio of topical products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. In June 2009, the Company announced that it entered into a license agreement with JH Direct, LLC for the exclusive worldwide rights to Transdel's anti-cellulite cosmeceutical product which utilizes the Company's Transdel(TM) technology. For more information, please visit http://www.transdelpharma.com.

Safe Harbor Statement

Statements made in this release that are not historical in nature constitute forward-looking statements. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. Please note that forward-looking statements are based on projections, that these projections involve judgment, and that individual judgments may vary. Moreover, these statements are subject to risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the uncertainty of the Company's future financial results and its ability to raise additional funds to support its operations, its ability to complete the required clinical trials and obtain FDA approval for Ketotransdel, the efficacy and the commercial success of any products it develops, the impact of competitive products or pricing, and technological changes. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. All forward-looking statements included in this release are made as of the date of this press release, and the Company assumes no obligation to update any such forward-looking statements.

[Camaro1093]

I'm hoping for that... I don't have much in it either way, but that kind of move would certainly be pretty sweet.

Well, according to the last statement by the CEO (Thomas Weisel Partners Conference), the results would be out this quarter. Today was the last day of the quarter, maybe they'll be out before the end of the week, hopefully so.

JMO.

GLTA LONGS!!

[BioSpecialist]

PIII RESULTS WILL BE POSITIVE ..

5$ + VERY SOON ----

[Camaro1093]

In the Thomas Weisel conference, the CEO seemed very positive about Ketotransdel, IMO. If I remember correctly, the CEO said that the next illness they will develop a drug for with their topical Transdel technology is for Osteoarthritis.

JMO.

GLTA!

[Camaro1093]

Transdel @ the Thomas Weisel Partners Healthcare Conference: http://www.veracast.com/webcasts/twp/healthcare09/79113113.cfm

[Camaro1093]

P3 results should be out soon, IMO.

JMO.

GL!

[derek4]

OK - Lebed

This stock is getting some attention because Lebed has got one of his one-month blue light specials pumping this. Now TDLP does have a product that has made its way to Phase III trials. Obviously they need $$$ for this. A legit question has got to be "Are they paying to pump this to get $$$ for the trials." That is, "Will be there be a PPS increase and then a selloff to secure those $$$." So far, no bites as the stock has decrease in price since the pump started. Any input??