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.
SIGA Technologies, Inc., Q2 2012 Guidance/Update Call, Aug 06, 2012
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts
Every recommendation goes through 3 layers of intense scrutinyquantitative, fundamental and technical analysisto maximize profit potential and minimize risk.
Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.