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CEL-SCI Corporation Releases Letter to Shareholders

eon went from about $3 to $27 on that news. The validation of the manufacturing facility is a critical step to starting this Phase III trial.

Our Phase III trial has been designed to remove many of the common clinical trial problems. We have identified the most common reasons for Phase III study failures or failure to receive approval to sell a drug, other than the drug not working, and they are:

1. Phase III study not reviewed by FDA and not acceptable to FDA:

Our Phase III study was reviewed in detail, and we have made changes

based on FDA's comments prior to commencement of the Phase III


2. Study too small:

Our study will enroll about 800 patients, a very sizeable number.

3. Clinical endpoint not relevant:

We follow overall survival of the patients, the gold standard. The

Clinical endpoint cannot be more relevant.

4. Change in treatment protocol between Phase II and Phase III without

additional studies:

We have made no such changes. Therefore, we expect the Phase II

results to be representative of the results one can expect in the

Phase III trial.

5. Insufficient attention to manufacturing issues:

We have validated our manufacturing process and built a dedicated

manufacturing facility for Multikine.

We believe that the success of this study will open cancer therapy to a whole new way of fighting cancer, one that is not toxic and one that works with the body, not against the body. We have high confidence that this study will be successful for the following reasons:

  • All clinical indicators support the finding of increased survival in Phase II.
  • The 10% increase in overall survival needed to meet the Phas

SOURCE CEL-SCI Corporation
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