3SOF

NVD: Jumps +30.74%; Vol +88%; Last 90 Min of Trading
Wednesday, January 02, 2008 16:21ET

During the last 90 minutes of today's session, shares of Novadel Pharma Inc (AMEX: NVD) demonstrated a strong UPWARD close relative to its 13:30 ET statistics. "Strong Closers" are determined by proprietary Knobias calculations performed during the last segment of each trading day.

sym: NVD       @13:30 ET        @CLOSE      % CHANGE
----------   -----------   -----------  ------------
PRICE              $0.39         $0.51       +30.74%
VOLUME           874,939     1,641,102     +87.57%
#TRADES          347           768      +121.33%
DAY-HI             $0.39         $0.53       LATE-HI
DAY-LO             $0.22         $0.22             N/A

Pipeline:
NovaDel has a robust pipeline of drug candidates in all stages of development, with one approved product in the U.S., several product candidates currently under late stage development, and multiple candidates in earlier stages of development and clinical review.
NovaDel's pipeline is composed entirely of oral spray drug candidates that were generated through the application of the Company's proprietary oral spray formulation technology to currently approved pharmaceuticals. This technology may enable more rapid delivery of drugs into the bloodstream than the original drug, which results in faster onset of action and potential patient benefits in compliance, convenience and safety. An additional advantage to NovaDel's development candidates is the time and cost efficiency resulting from the use of the FDA's 505(b)(2) regulatory pathway.  This abbreviated regulatory mechanism allows for the use of existing efficacy and safety data contained in the original drug application.  The steps in NovaDel's drug development process typically involve formulation of the candidate into an oral spray, successful completion of pilot and definitive studies followed by focused safety studies in human subjects.  These highly efficient clinical trials are followed by regulatory submission.  This process may take 3 years compared to the typical 8 to 10 years for development of a new pharmaceutical candidate.  Substantial cost savings may also be realized through NovaDel's drug development strategy: generally, the development cost for products utilizing the 505(b)(2) pathway is less than $5 million.

latest results:
NovaDel Reports Financial Results for Third Quarter 2007
Wednesday, November 14, 2007 16:07ET

FLEMINGTON, N.J., Nov 14, 2007 (BUSINESS WIRE) -- NovaDel Pharma Inc. (AMEX: NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, reported financial results for its third quarter ended September 30, 2007. For the quarter ended September 30, 2007, NovaDel reported a net loss of $2.4 million, or $0.04 cents per share, compared to a net loss of $5.3 million, or $0.09 cents per share, for the previous quarter ended June 30, 2007.

The net loss in the quarter was primarily attributable to continuing expenses associated with the Company's late-stage candidate, zolpidem oral spray, indicated for the treatment of insomnia, as well as its advancing candidate, sumatriptan oral spray, indicated for the treatment of migraine headaches. Total operating expenses for the current quarter were $3.0 million, as compared to $5.3 million and $5.6 million for the previous two quarters. This reduction in the current quarter's operating expenses was largely due to lower research and development expenses associated with the Company's zolpidem product candidate, which is targeted for NDA submission before the end of this year. In addition, a $0.3 million non-cash credit was recognized during the quarter for stock compensation primarily related to the modification and accelerated vesting of certain stock options. In contrast, the Company recognized $0.5 million of stock compensation expense in each of the first two quarters of 2007. As of September 30, 2007, the Company's cash, cash equivalents and short-term investments were $9.6 million and working capital was $6.9 million. Given the current and desired pace of development of its product candidates, the Company is reporting sufficient cash on hand through March 31, 2008, to fund further development of zolpidem oral spray and sumatriptan oral spray. Funding for the Company's future development activities could be secured through new strategic partnerships, the sale of its common stock and/or other forms of securities. The Company offers no assurances that it will be able to obtain the necessary funding in a timely manner, if at all.

The Company also reported today that it is reaffirming its guidance regarding its plans to file a New Drug Application with the FDA for zolpidem oral spray prior to the end of 2007.




chart:

NVD: FDA Accepts NDA Filing for ZolpiMist(TM) Oral Spray for Insomnia
Wednesday, January 23, 2008 09:28ET



NovaDel Pharma Inc. (NVD) announced that the FDA has accepted for filing its New Drug Application (NDA) for ZolpiMist(TM) (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. The company anticipates the FDA will complete its review by the end of the year. Previous results have demonstrated bioequivalence between ZolpiMist(TM) and Ambien(R).

ON WATCH!

NovaDel Pharma Inc. (NVD:AMEX)

Rating: Market Outperform
Risk: High
Target Price: $1.75 (January 24, 2008)
With the FDA accepting ZolpiMist NDA for review, 2008 could see the first significant product launch

Investment Conclusion:
Yesterday, NovaDel announced the FDA's acceptance of the NDA filing for ZolpiMist™
(Ambien™). We believe that the NDA was submitted for review during November 2007, which
puts the PDUFA date (potential approval) at September 2008. It is our opinion that the
ZolpiMist NDA was supported by comprehensive clinical and manufacturing data and has a
high likelihood of getting regulatory approval. After a forgettable 2007, coupled with the
ongoing cash crunch, the NDA submission marks the first step in management efforts at
regaining investor confidence. In the near term we expect NovaDel to ink a couple of minor
sales and marketing agreements, starting with NitroMist™ (approved product for Angina) and
potentially a deal for the European market. Management is also actively seeking a marketing
partner for ZolpiMist™ and we believe that a significant deal could be structured during 2H
2008. Management might also need to access the capital markets for additional financing. We
reiterate our market outperform rating, however, we are lowering our price target to $1.75 from $3.00 to account for the delays in other pipeline products. Risks to achieving this target include clinical trial failure, failure to gain regulatory approval, competitive risk, and share volatility and dilution.

Key Points:
• Extensive manufacturing and stability included in the NDA package should address scale up
concerns.
• Near term licensing deals should validate the technology and act as a strong catalyst.
• Lowering our 12-month price target to $1.75 from $3.00 to account for pipeline delays.

http://www.boenningandscattergood.com/news/files/NVD%20(2008.01.24).pdf

chart:

Nice looking...