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CVM, Timing, And Phase 3

|Includes:Cel-Sci Corporation (CVM)

I have heard chatter about not believing Geert and his cohorts over at Cel Sci (NYSEMKT:CVM). Look, it's been a long journey. But I still see CVM as one of the most opportune biotech investments on the market right now. Obviously all of their chips are in the Multikine basket right now, and occasionally I go to their site to get info. The info below hasn't changed, but after reading it, I can tell you I feel more confident with this stock.

I am certainly long CVM, and I plan to be long CVM for a while. But even for the traders out there who get impatient, any news on Multikine will trigger a spike. I have a few shares that I will dabble with and sell for a profit (outside of my base investment in CVM). But with 4 more years of a biotech friendly President, I suddenly feel more bullish on CVM.

Here are some updates from their site:

Steps taken to reduce the risk of failure of the Multikine Phase III trial:

The most common reasons for Phase III study failures or the failure to receive approval to sell a drug, other than the drug not working, are:

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

Multikine Phase III study was reviewed in detail and changes were made to the Phase III protocol based on FDA's comments.

   
2. A study that is too small:

The Multikine study will enroll 880 patients, which is a very large number, particularly in this population, and one that enables the study to be appropriately powered to evaluate achievement of the study endpoints.

   
3. The clinical endpoints are not relevant:

The Multikine study follows the overall survival of the patients, which is considered to be the "gold standard" of endpoints in clinical trials. The clinical endpoint cannot be more relevant.

   
4. A change in treatment protocol between Phase II and Phase III without additional studies:

The Multikine Phase III study is the same as the Phase II study; no changes were made. Consequently, we reasonably anticipate the potential that the Phase II results could be representative of the results that we hope to achieve in the Phase III trial.

   
5. Insufficient attention to manufacturing issues:

The Multikine manufacturing process is validated and CEL-SCI has built a dedicated manufacturing facility for Multikine. The manufacturing facility is designed and built to meet US FDA and EU regulations and requirements for the manufacture of sterile injectable products (such as Multikine).

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Disclosure: I am long CVM.

Stocks: CVM