| CytoDyn has been meeting with Principle Investigator | | | | They have give their response to the FDA and under |
| Dr. Jay Lalezari at Quest Clinical Research in regards | | | | Section 117 (C)(3) of the Food and Drug |
| to finalizing their work towards a 'Phase 2' trial of | | | | Modernization Act of 1997, they have only 30 days |
| 'Cytolin®', which is an immune therapy. It works | | | | upon receipt of a complete response, to act on it. |
| along with our human immune systems, not to cure, | | | | This whole process has brought the FDA under close |
| but to control, the HIV infection. It's full of promise, | | | | scrutiny, giving fuel to many conspiracy theories, due |
| and this is known because it was actually used about | | | | to their unwillingness to approve something that is |
| 2 full years before the 'antiretroviral cocktails' came | | | | the direct opposite of something they wouldn't |
| out. | | | | approve before. Raptiva was an antibody that was |
| The main goal of this meeting is to decide on how to | | | | supposed to do the exact opposite of what |
| proceed in order to get Cytolin® approved by | | | | Cytolin® does, and the FDA responded the same |
| the FDA. Standards for AIDS treatments grow with | | | | way. |
| each passing year, as new studies and new drugs | | | | The FDA is said to be notoriously underfunded and |
| evolve. It's hoped that Cytolin® can help to | | | | understaffed. This brings up other questions. If the |
| control the HIV and thus delay the need for | | | | FDA is so inadequate, and its approval isn't |
| someone to begin the antiretroviral therapy. | | | | considered to imply that drugs are safe, then why |
| In essence, Cytolin® is a monoclonal antibody. It's | | | | should drug companies spend billions of dollars for |
| basically antibodies from mice. Researchers believe | | | | that approval? Isn't this one of the factors leading to |
| that there's a flaw in the human immune system. | | | | the high cost of health care? This looks to be a real |
| That's because only humans get sick from the HIV | | | | mess. |
| virus. Animals get the virus, but we get sick, and | | | | The sad part about this country is that, when a |
| they don't. Thus the conclusion that our immune | | | | company KNOWS it has a drug that will save lives, it |
| systems aren't all they should be. They believe that | | | | can still take it 20 years or more to get it approved. |
| Cytolin® will 'correct' the immune system flaw, | | | | That's ludicrous, and we should be ashamed. An |
| which is not the same as they've been doing, trying | | | | example is in the case of a couple of oncology drugs |
| to 'reconstitute' the immune system. | | | | - Avastin and Erbitux. |
| The success for Cytolin® looks good, but getting | | | | CytoDyn has been a part of a documentary about |
| it approved is an uphill battle. The FDA requested a | | | | the company, but it hasn't been released yet either. |
| test from CytoDyn in which CytoDyn had to respond | | | | CytoDyn is to be applauded for the work they do, |
| that the request was impossible to fulfill. But the | | | | not only with Cytolin® and Aids, but other areas |
| commitment of CytoDyn has not been hampered. | | | | as well. |