This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

SIGA Technologies, Inc., Q2 2012 Guidance/Update Call, Aug 06, 2012

Regarding our business operations, in particular, ST-246 and the BARDA contract, I want to highlight a few areas of progress. First, the labeling plan for ST-246 has been submitted and is being reviewed by the FDA. We are eligible for $12 million milestone payment from BARDA once the labeling plan is approved by the government. With respect to the delivery schedule for ST-246, we continue to expect to begin delivering the drug into the Strategic National Stockpile by the end of the first quarter 2013, and we also continue to expect to deliver the full 2 million courses under the contract within 24 months of the date of initial delivery.

As mentioned on previous calls, the size and exact timing of each delivery will be determined in the future based on a variety of factors. Once we meet the 500,000 course delivery threshold, as noted in the contract, we'll be able to invoice BARDA for timely payment of all amounts then due. When we deliver courses of ST-246 into the SNS under the current procurement contract, our plan is that the courses will have a daily dosage of 600 milligrams over a 14-day regimen. We have set daily dosage at 600 milligrams per day after discussions with BARDA, the FDA and CDC. While our discussions have included the FDA, the 600-milligram dosage does not represent an FDA-regulatory decision on dosages at this time. It is our understanding that the FDA will express its formal regulatory decision on dosage after an NDA has been filed for ST-246, consistent with the timing and process once these -- with other drug candidate.

Shifting gears, let me spend a minute discussing the progress we've made on the intravenous formulation, the IV formulation, of ST-246. As you will recall, in addition to an oral formulation, we are pursuing an IV formulation for the drug. This effort has been steadily progressing, and we continue to target an IND filing for the IV formulation by the fourth quarter of this year, and it may happen in the third quarter. Work on the IV formulation is important because it seeks to address an unmet need of a vulnerable segment of the population.

2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free


Chart of I:DJI
DOW 16,912.29 +122.10 0.73%
S&P 500 1,995.83 +15.91 0.80%
NASDAQ 4,791.1520 +42.7910 0.90%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs