This is my thinking regarding ArTiMist situation, always...

This is my thinking regarding ArTiMist situation, always interested in other views and information.

Suda want approval to market ArTiMist for the treatment of severe pediatric malaria and its use as a pre-referral. This was stated in a 2014 update which also mentioned prospective partner interest. Around this time the WHO called for intensified efforts to withdraw oral artemisinin-based monotherapy from the market. (only rectal formulations for pre-referral treatment and injectable formulation for the treatment of severe malaria should be deployed).

According to MMV RAS pre-referral in not attractive for manufactures, only moved forward with its support and is meeting key unmet need. Potential risk of misuse by adults is low not only due to culture but trials show it's unsuitable.

Novartis have delivered over 880 million treatments without profit to malaria-endemic countries with the support of MMV. Sanofi have only recently gained prequalification of Artemether injection.

So in my opinion ArTiMist approval is an uphill battle because Suda need its full approval. This approval plus MMV support is required to be of interest to big Pharma.

Also, on a different topic, expecting more scrutiny for cannabis after FDA safety alert for vapour products containing THC.

https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/tetrahydrocannabinol-thc-containing-vaping-products-vaping-illnesses