Cel Sci Corporation (CVM)

[Fosco1]

Survival models : focus on dropout rates
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Many of you have expressed interest regarding survival models for Cel SCI.

-How is Standard of Care Overall survival ?
-How much % could be dropouts ?

About SOC survival :
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We have expressed the firm belief that Oscc observed in most of the sites of the study _ from which 62 out of 101 are in developing countries_ are mostly not HPV related and mostly affecting a population which has low socioeconomic standards and poor ability to pay for insurances. (HPV related oscc have a much better cure rate)
We have seen from recent studies how disastrous survival was in Bulgaria/ Thaïland / Mainland China : heavy smokers and drinkers, likely little HPV prevalence, less private insurances.
We do therefore believe that observed OS in the clinical trial treated by SOC only is far below the observed survival in North American statistics (SEER Db) which is biaised by HPV occurrences and closer from what Cel SCI states as an unchanged survival of near 50% OS @ Y5 in absolute numbers

Regarding Dropouts rates :
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We explained in the following thread why we believed it is low :

https://finance.yahoo.com/quote/CVM/community?p=CVM&messageId=9808e8bc-d35c-49de-9f48-1139bb3551fe&replyId=b49ce6bb-0461-4ec7-bb5a-d3cbcb45416f&bcmt=1

We can also use this Taïwanese study as a benchmark :

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5384671/

Excerpt :
“There were 24,335 newly diagnosed OCSCC patients from 2004 to 2010 in Taiwan. Carcinoma in situ was found in 1,864 patients (7.7%) whereas 469 patients (1.9%) had multiple primary cancers or distant metastasis. In addition, 362 patients (1.5%) who did not receive any treatment during the follow-up period and 397 patients (1.6%) who had incomplete records were excluded. Consequently, 21,263 patients (87.3%) were included in our final analysis.”

What this does mean : once screening is done (inclusion criteria applied in the case of cell sci) they were left with 22002 elligible patients (24 335 less 1 864 less 469 patients). On those eligible patients 362 (1,6%) did not receive SOC treatment 397 (1,8%) had incomplete records.

So we can consider that Dropouts rate in this example of SOC for OCSCC treatment for 22000 patients was of 3,4%

In conclusion :
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We are in line with our models.
- With 5Y overall survival for SoC close from 50% (lets take 53% as a conservative assumption)
- With dropouts rates likely low (lets take 5% as a conservative assumption)

All statistical models taking into account current observed survival in the PhIII clinical trial (less than 298 events so far June 2019) show that Multikine improves survival more than 10%