I do remember... wow that feels like an eternity ago, and still we do not have a clear path forward for FDA approval.
Every so often I yap about this "synthetic potential" and now years later the NYT decides to write about it. I suppose with Ebola and ISIS in the news now this a logical article to see in print. ISIS is the ideal group to see hiring a foundry to whip up a batch for their destructive conquests. They would salivate at the idea of launching this kind of attack on the mainland US. In the Ebola fiasco we clearly see that our gov't is unprepared for an outbreak. A bad mix of political correctness and hubris has left us with a scatterbrained response thus far. I have yet to hear a sensible explanation as to why we have not secured our borders or at the least instituted a commercial travel ban.
Author of this article, Leonard Adleman just grasped what we have been discussing on this board for years....The Synthetic Potential. Genomic Foundries are out there and groups like ISIS are sophisticated, capitalized, and sick enough to use them to deliver this nightmare scenario, especially after seeing how unprepared and scatter brained the CDC is in their response to Ebola.
"...If you search online, you can find the sequence for the smallpox genome. It is a word written with the letters A, T, C and G. The word is about 185,000 letters long. It is the word that tells cells to make smallpox viruses. The sequence was stored on a computer in the early 1990s, when a research team led by J. Craig Venter obtained it using a biotechnical process applied to a sample of the virus.
Of course, a word in a computer file cannot kill you. Well, yes and no. In the 1990s, I ran a biotechnology laboratory. In my lab there was a machine much like a soda dispenser, only in this case the reservoirs were filled with chemicals. If I typed in a short word of my choice using the letters A, T, C and G, the machine would squirt one chemical after another into a test tube. When it was done, the test tube would contain trillions of molecules of DNA. Each would look like a necklace, with molecules of adenine, thymine, cytosine and guanine (the building blocks of DNA) strung according to the word I had typed.
At that time, the 10,000-letter sequence of the H.I.V. genome was available online. I contemplated using my machine, together with well-known biotechnical methods, to create, de novo, the H.I.V. genome — an actual molecule identical to that found in H.I.V. viruses living in the wild. I had reason to believe that inserting such a synthetic molecule into a living human cell would cause the cell to manufacture full-blown H.I.V. viruses that could then be transmitted from person to person and cause AIDS...."
CMX001 is starting to look like the Silver Bullet we had hoped for in ST-669 back when Siga was still a motivated research and development company. CMRX traded at 52 week highs today on this news at over 10x average volume.
The last I heard Duncan was in very bad shape. If CMX001 brings him back from the brink, and assuming it works as well on smallpox, this would be yet another reason for BARDA to weight its purchase over ST-246...that is, if they are still planning on procuring the follow on courses that Chimerix protested Siga initially being awarded. Parsons' non-speculative assessment of ST-246 is looking more and more speculative by the day, as alternatives for the stockpile look more and more attractive.
Too cheap for Ronnie P to ignore. If you believe a common sense ruling will come out of the DSC, it is difficult to ignore these prices. I may have to follow the money here.
"SIGA anticipates requesting an appeal of the determination of Nasdaq pursuant to the Nasdaq Listing Rules. SIGA’s common stock will remain listed on the Nasdaq Global Market pending the outcome of the hearing."
How can you be so certain that they will fail the appeal?
"Foreign orders were never big for the smallpox vaccine, so why would they care about an antiviral if they aren't convinced threat is significant enough to stockpile vaccine? "
Canada's PHAC describes possession of freeze dried and frozen liquid formulations. Many countries have a stock of vaccine. The WHO is actively looking to grow their stockpile, and per their estimates as of Nov 2013 there is a long list of countries holding vaccine stockpile.
Millions of doses
United Kingdom 80
Other countries 50-100
"As shareholders you should be fearful that these same people are the ones deciding SIGA's course in this process."
Last time I checked, Don Drapkin was no longer at Siga.
"Another drug or vaccine could come up and knock 246 to the sidelines"
That drug will most likely be CMX001 as Chimerix appears to be on track to secure FDA approval before Siga. Foreign orders have not come in for ST-246 as longs had been hoping for, most likely because it lacks FDA approval. Those orders may go in to CMX after it obtains approval and BARDA validates it by stockpiling it as the second antiviral for the SNS. The idea that Siga's future sales could be determined with any degree of certainty, at the time of the breach, is utterly ridiculous.
On September 18th Siga included the paragraph you posted in their 8-k. You conveniently left out the last sentence of that paragraph which suggests that Siga will not be delisted as you and others are broadcasting.
"The determination of Nasdaq was pursuant to Listing Rules 5101, 5110(b), and IM-5101-1. SIGA anticipates requesting an appeal of the determination of Nasdaq pursuant to the Nasdaq Listing Rules. SIGA’s common stock will remain listed on the Nasdaq Global Market pending the outcome of the hearing."
Business as usual
From the 8-K:
SIGA commenced the Chapter 11 Case to preserve and to assure its ability to satisfy its commitment to supply Tecovirimat, an antiviral smallpox drug being delivered to the U.S. Strategic National Stockpile under the Project BioShield Act of 2004. SIGA intends to operate during the chapter 11 period as a going concern for the benefit of the U.S. government and all economic stakeholders. The chapter 11 filing will ensure that SIGA continues to supply Tecovirimat pursuant to its contract with the Biomedical Advanced Research and Development Authority (BARDA), and is able to pursue what it believes is a meritorious appeal of a pending Delaware Chancery Court proceeding.
From the 8k:
1. SIGA anticipates requesting an appeal of the determination of Nasdaq pursuant to the Nasdaq Listing Rules. SIGA’s common stock will remain listed on the Nasdaq Global Market pending the outcome of the hearing.
Siga Technologies Inc., the biological warfare defense firm supplying the only smallpox drug for the U.S. strategic stockpile, filed for bankruptcy to avoid paying a court bond after losing a contract lawsuit and to preserve its ability to make the medicine.
The filing allows Siga to challenge an expected damages award to competitor PharmAthene Inc. (PIP) of as much as $232 million without posting the bond, Siga said in a Chapter 11 petition today in Manhattan bankruptcy court. The move ensures Siga can continue supplying the drug, called Tecovirimat, intended for use during a possible biological terrorist attack, Siga said.
Enforcement of the expected judgment in favor of PharmAthene “would threaten Siga’s viability, its ability to produce and deliver our smallpox drug,” Siga Chief Executive Officer Eric Rose said in a statement today. “We remain committed to performing under Siga’s contract.”
Rose said Siga can get the damages reduced on appeal by challenging the way they are calculated.
News on Think or Swim has a blurb by Kevin Kingsbury echoing your thoughts. He states that unlike companies with bloated balance sheets or slumping sales companies like Siga will use chapter 11 protection to provide an environment from which to persue legal action. ..in this case siga could continue their appeal efforts with protection from the bankruptcy court against PIP seeking damages. Kingsbury says this could be a good thing.