Well, here's the email correspondence between Dan and I regarding some questions/accusations Adam and his followers had of CVM. Take it for what it's worth. Just wanted to share before it hits my stop.
Dan,
I would like an update on the following:
1. Has the FDA granted Cel-Sci (CVM) permission to test its experimental H1N1 flu drug in patients or the white blood cells of hospitalized patients?
Dan: The FDA has given CEL-SCI permission to start preparations, subject to final approval, for a test of hospitalized H1N1 patients.
2. CEL-SCI had outstanding convertible notes, options and warrants which as of November 30, 2008 could potentially allow the holders to acquire up to approximately 174,100,000 additional shares of its common stock. Is this true?
Dan: VIENNA, Va., Sept. 2 /PRNewswire-FirstCall/ -- CEL-SCI Corporation (NYSE AMEX: CVM), a developer of vaccines for the prevention and treatment of infectious diseases and a late-stage oncology company, announced today the elimination of Series K convertible notes (the "Notes"). The Notes, which had an initial principal value of $8.3 million, were issued in August 2006, and were convertible into common stock.
"The elimination of the Notes significantly strengthens the Company's balance sheet and removes a potential overhang for our shareholders," said Geert Kersten, CEL-SCI Corporation's Chief Executive Officer. "Over the past three months, we have considerably improved our financial condition, allowing us to move forward in the development of several of our promising clinical platforms."
3. CEL-SCI has had only limited revenues since it was formed in 1983. Since the date of its formation and through September 30, 2008 CEL-SCI incurred net losses of approximately $124,696,000. CEL-SCI has relied principally upon the proceeds of public and private sales of its securities to finance its activities to date. Is this true?
Dan: Yes. In R&D, first you spend a lot of money. Later on, if you've done some good sceinces, you have a product that you can sell, a process that you can license, an IP estate you can sell, etc.
4. Why were there consistent Press Releases released by Cel-Sci in September which raised the pps to a high of $2.10 and we haven't heard of anything since then, which caused the pps to drop to it's current level.
Dan: Unfortunately, CEOs don't control the flow of external news events. Like epidemics. They do control some internal time lines.
But there is an ebb and flow in these situations.
5. CEL-SCI does not expect to develop commercial products for several years, if at all.
Dan: It normally takes several years to bring products to market.
However, during epidemics, the regulatory process for drugs that address that situation is speeded up.
Additionally, the product demand increases significantly.
We may or may not have an H1N1 epidemic this year.
If we do, this will impact the government funding and government regulatory processes and their time lines.
CEL-SCI has had operating losses since its inception, had an accumulated deficit of approximately $(135,000,000) at June 30, 2009 and expects to incur substantial losses for the foreseeable future. Is this true?
Dan: The losses and deficit are true, the expectation of substantial losses for the foreseeable future is not.
The correct word is anticipation, not expectation.
The company anticipates losses and is prepared for them. It has enough cash on hand to get half way through the Phase III clinical trial for MultiKine. Its expectation is that between LEAPS, MultiKine, CEL-1000, and CEL-2000; there might well be a potentially successful platform or drug that might attract a Big Pharma partner, Or there might be a valuable IP estate which it will be able to monetize. Or there might be government funding, particularly in their H1N1 work.
6. The published phase II study of MK in H&N cancer did not have a proper control arm. Is this true?
Dan: It was not a double-blinded clinical trial. It was not supposed to have a control group. It was designed to find out if the drug was tolerable at specific doses and if it seemed to have a positive effect on the test group. It was successful enough that the FDA has given CEL-SCI permission subject to final authorization, to run a Phase III Clinical Trial.
AI
