Personally, I think that this is a matter of how to make the system work as proof of concept has occurred. Here are some hard facts that i find relevant to judging this product..
1. only one person has ever been cured of AIDS, meaning that they are virus free without a daily regimen of drugs. That is the Berlin patient who received a bone marrow transplant for Leukemia from a donor that was homozygous for a deletion at amino acid 32 in the CCR5 gene.
2. People who are homozygous for the delta 32 CCR5 mutation do not get AIDs even though they are exposed to HIV and have antibodies to the virus.
3. Clinical trials have looked at what happens when AIDs patients go on 12 week holidays from antiretroviral drugs. On average, during the first 8 weeks of HAART holiday cd4 counts are cut in half and viral load increases on average 3.5 log10.
4. To date SGMO has used their product to alter the cd4+ T cells of 21 AIDS patients. The first 15 were used for safety studies and the data from those show that rhe treatment is safe beyond 2 years now, that the T cells survive and circulate throughout the body including the gut mucosa and that the altered T-cells respond to immune challenges. T cells have been shown to survive anywherer from 1year to >10 years in the body.
5. Six of the 21 treated patients have undergone a 12 week HAART holiday. All patients showed an initial jump in VL, although the timing was delayed compared to historical data. Four of these patients had decreasing viral load starting at week 8-9 and one patients viral dropped to undetectable levels by week 12. The protocol required the patient to return to therapy and be followed for several years.
6. The single patient with undetectable VL was a heterozygote for the delta 32 CCR 5 mutation. Viral load decrease was directly proportional to the number of T-cells that had 2 copies of the delta 32 CCR5 mutation.
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