Keep An Eye On CBLI...

listen to the HEPH CC. Protectan is literally years behind Neumune, which has already met all the HHS requirements per their procurment. HHS is lying if they said that it did not satisfy the technical requirements. HEPH is requesting a "debriefing" from HHS at which they should learn what excuses HHS has. per the CEO and COO, everyone at HEPH went into work yesterday in full expectation of a contract award for ARS from HHS. they were blindisided by the end-of-day RFP withdrawal and no explanation has yet been given to them as to any technical shortcomings in their responses to the RFP, as amended.

HEPH has a lot of friends in Congress who would block any runaround by CBLI. a CBLI "runaround" in the works with leaked information would get SEC a lot more angry than they did over the back-dated stock options. it *also* would be tied up in the courts for years as a botched procurement. look at some recent federal court cases reversing some big procurement decisions by DoD for examples.

my advice is to bet on the tortoise here, not the hare. Neumune is *still* being developed for hospital-acquired infection and if approved for that indication, it could be used off-label for ARS.

 

DoD is exempt from FDA/HHS regulation when it comes to protecting the troops. as Hollis just said, DoD was "hoping" to "piggyback" on a Project Bioshield procurement, but they are free (now) to go ahead with a military procurement (where Neumune could *only* be given to military personnel).

CBLI has not been mentioned on the HEPH CC, even in the Q&A, which just concluded. CBLI is a fringe player on the margins of the ARS market with only fools pushing up their share price.

when i first called the Buy this morning on HEPH it was jumping between $2.90 and $2.96 as that first post was being written, which was posted before the CC Q&A. HEPH is now at $3.03 - $3.05 right after the CC concluded.

to be honest, i'm not even looking at the CBLI quote. only fools are doing the buying there.

 

If HHS is now doing an illegal side deal with CBLI (involving leaked info and insider trading) to cheat HEPH out of the contract, you will be seeing a lot of fireworks coming from Congressional hearings. Remember that HEPH is from California and so are Reps. Waxman and Pelosi.

HHS' authority under BARDA is delegated to them by Congress. Congress can tell HHS what to do by by appropriating specific funds for ARS preparedness, and Congress could then be taking charge of this seriously botched procurement, where HHS notified interested parties by e-mail of the cancellation before the market closed yesterday (despite HEPH's repeated requests that they do not release material information during normal trading). See link below for registration ... though they will probably "hide" any new RFP by giving it a new ID# and name.

HHS is now saying that this RFP is totally dead, with their spokesperson Wolfson saying yesterday that a new RFP will be issued, so signing up at the page below now may be too late to get any useful info, but getting the e-mail announcement yesterday, got a lot of selling going just before the market closed. You can register for updates at this page:
http://www.fbo.gov/spg/HHS/OOS/OASPHEP/DHHS-ORDC-DDA-05-12/Attachments.html

If you go over the RFP and its updates and compare them to the news releases and scientific papers at HEPH website, it's very clear that HHS is outright lying if they say that HEPH's submission did not satisfy the requirements. This is a scandal.

If HHS is in bed with CBLI to cheat HEPH out of a contract they should have been awarded without question, then wait until the crap hits their fan. You wouldn't want to be long CBLI when that news hits.

 

Check this out. Congresisonal Reps. Thompson and Langevin issued a press release, which i'm having a hard time finding, but it was the basis for this news story.


http://news.yahoo.com/s/usnw/20070308/pl_usnw/the_future_of_bioshield_in_question

The Future of BioShield in Question? Wed Mar 7, 7:06 PM ET

To: MEDICAL EDITORS


Contact: Dena Graziano or Todd Levett, +1-202-225-9978, both of the House Committee on Homeland Security - Democratic Office


WASHINGTON, March 7 /PRNewswire-USNewswire/ -- Today, the Department of Health and Human Services cancelled a BioShield RFP for a medical countermeasure to treat Acute Radiation Syndrome. The original RFP for an ARS countermeasure was to be closed on February 23, 2006, with the original award date set for June 2006. That award date was extended to September 15, 2006, then November 30, 2006, then January 31, 2007, and finally to today, March 7, 2007.


According to HHS, the RFP was cancelled because none of the companies met the requirements, even though HHS had previously informed a candidate company that they were in the "competitive range." In addition, the company itself claims it has met all the requirements.


"It seems as though HHS has dropped the ball," said Congressman Bennie G. Thompson (D-MS), chairman of the Committee on Homeland Security. "By cancelling this RFP, the future of Project BioShield remains uncertain. The cancellation in December of its largest contract for a next-generation anthrax vaccine was itself a serious blow to the credibility of the program. Now we have another major breakdown with the project...what's next?" asked Congressman Thompson.


"BioShield will cease to attract companies to participate if RFP's and contracts continue to be cancelled. This latest action reaffirms our belief that rigorous oversight of BioShield is warranted, and we intend to conduct that oversight, starting with a hearing next month," offered Congressman James Langevin (news, bio, voting record) (D-RI), chairman of the Homeland Security Subcommittee on Emerging Threats, Cybersecurity, and Science & Technology.

FOR MORE INFORMATION:

Please contact Dena Graziano or Todd Levett at (202) 225-9978.

SOURCE House Committee on Homeland Security - Democratic Office

 

Here it is:
http://hsc-democrats.house.gov/press/index.asp?ID=186

The Future of BioShield in Question?


FOR IMMEDIATE RELEASE:
Wednesday, March 07, 2007

Wednesday, March 7, 2007 (WASHINGTON) – Today, the Department of Health and Human Services cancelled a BioShield RFP for a medical countermeasure to treat Acute Radiation Syndrome. The original RFP for an ARS countermeasure was to be closed on February 23, 2006, with the original award date set for June 2006. That award date was extended to September 15, 2006, then November 30, 2006, then January 31, 2007, and finally to today, March 7, 2007.

According to HHS, the RFP was cancelled because none of the companies met the requirements, even though HHS had previously informed a candidate company that they were in the “competitive range.” In addition, the company itself claims it has met all the requirements.

“It seems as though HHS has dropped the ball,” said Congressman Bennie G. Thompson (D-MS), Chairman of the Committee on Homeland Security. “By cancelling this RFP, the future of Project BioShield remains uncertain. The cancellation in December of its largest contract for a next-generation anthrax vaccine was itself a serious blow to the credibility of the program. Now we have another major breakdown with the project… what’s next?” asked Congressman Thompson.

“BioShield will cease to attract companies to participate if RFP’s and contracts continue to be cancelled. This latest action reaffirms our belief that rigorous oversight of BioShield is warranted, and we intend to conduct that oversight, starting with a hearing next month,” offered Congressman James Langevin (D-RI), Chairman of the Homeland Security Subcommittee on Emerging Threats, Cybersecurity, and Science & Technology.


# # #

 

Well BioB I sold CBLI. None of the companies mean none of the companies. Now I wonder about that Akorn and their pill. Akorn has received a $21.9 million contract for 450,000 units of Ca-DTPA and Zn-DTPA, which treats internal contamination from radioactive elements.... that's in the bank Bio and now I wonder if the plan isn't just to stockpile this pill.
~stoney.

 

Any generic drug maker could easily do that job to FDA standards. How much are they getting a dose? Over $40 per dose? A Mylan or a Teva could easily have underbid Akorn.

They're "clearing agents" like Prussian Blue (for CS and Th) and EDTA (for Pu) intakes.

When there was a tritium intake a while back, they used beer. Its mechanism of action is the same as the others listed above.

Read the DoD RFP that came out on Feb. 16, which is probably the reason for the rise in CBLI, though someone was definitely trading on non-public info because the strong rally began at least a week before that was released. See http://www.smdc.army.mil/contracts/rfp/07-r-0002/medrad.html

 

from:
http://money.excite.com/jsp/nw/nwdt_ge.jsp?news_id=cmt-354p2762&feed=cmt&date=20061220

Up to one hour after exposure? And that claim is based on mice, not monkeys. Sounds like a sure thing ... Not!

 

I haven't the foggiest idea why DoD is focusing on GI syndrome and ignoring neutropenia. They're going against all the standard guidance books for treating people exposed to radiation in emergencies. They're going against common knowledge among nuke safety experts, and all public data available from IAEA, FDA and HHS, CDC, DOE, NRC, and even DoD/AFRRI itself (where the DoD experts at AFRRI have been pushing Neumune since 1997).

Could DoD now have some NEW reason for focusing on GI syndrome where the basis is classified? Sure. Maybe, but i doubt it. Call up any professor who teaches health physics or radiation protection medicine. I'll bet that they'd be as baffled as i am.

Yup. Whatever their reason is for focusing on GI syndome is not in public domain, or, if it is, it's on the fringe. I saw a message board posting that said the GI syndrome requirement from DoD was based on something that came out of an Erasmus University (which i've never heard of), but Google served up a (single) 1982 (and pre-Chernobyl) issue of the journal Radiation Biology as the source: http://taylorandfrancis.metapress.com/content/b3manhv4ndxc/?k=ARS after doing this Google search: http://www.google.com/search?source...19,GGLG:en&q=erasmus+university+"Gi+syndrome" which found this snippet of text in just one hit (while my own posts right here are coming up much more frequently on my searches):

HHS knows that it's the bone-marrow syndrome that kills with ARS, and not GI syndrome. HHS said so in their RFP Q&A right here (and pretty much everywhere throughout the RFP/RFI documents): http://fs1.fbo.gov/EPSData/HHS/Synopses/37271/DHHS-ORDC-DDA-05-12/ARSRFPAm02.pdf , which was reached from this page, previously posted here: http://www.fbo.gov/spg/HHS/OOS/OASPHEP/DHHS-ORDC-DDA-05-12/Attachments.html

 

OK. Basically, ever since Chernobyl (April/May 1984), we know for sure that it's the bone-marrow syndrome (not GI) which kills people with ARS.

Besides the testes (which are highly radiosensitive) in men, and a human zygote/embryo/fetus in a pregnant woman, the cells in the body which are the most sensitive to penetrating radiation (gamma or neutron) are the cells of the bone marrow. The body stops producing WBCs as a result of marrow suppression, and the person with ARS becomes subject to sepsis because their body's ability to fight infection disappears. There are plenty of ways to estimate a person's acute radiation dose based on WBC counts taken several times a day. Canberra is one company that sells software to do the calculations: http://www.canberra.com/products/536.asp .

So, think about GI cells in comparison to bone marrow. The GI tract is very good at handling environmental "insults." Just as the skin is a natural barrier that protects the body from external threats, the cells of the GI tract are exposed to whatever we ingest, which can include toxins of all sorts. That is why the GI tract is not damaged if a person is exposed to "whole body" external radiation at the 4 Gy level, the approximate LD50 (7 day) for bone-marrow syndrome.

OK. Yes, the very first sign of ARS is prodromal vomiting, which is caused by radiation dose to the stomach. But that vomiting stops within a day or two; it's not a cause of death from ARS.

The DoD procurement makes no sense.

There is something very rotten in Denmark here. I hope that the SEC will be interested in looking into the very obvious insider trading that began BEFORE the 2/16/2007 RFP announced by DoD. This is very fishy, to put it mildly.