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["ATTRIBUTE","TARGET (IDEAL)","MINIMALLY ACCEPTABLE","COMMENT"]
["Target species","all","single species ","L. tropica and L. braziliensis higher priority"]
["species dependent Rx response","No, one drug treats all","Yes","Best if some benefit for other Spp, so Speciation is not required"]
["Safety","No deaths, no SAEs","No Severe or Serious AE","Minimum patient-health system contact"]
["medical supervision required?","none","Primary Health Care (minimal contact)","Broader access if no med care / supervision needed"]
["Tolerability","Well tolerated","Well tolerated in >90%","Broader access if well tolerated"]
["Common Terminology Criteria for AE v3.0 <http://ctep.cancer.gov/forms/CTCAEv3.pdf> ","All AES ≤ grade 1","No systemic AE > grade 2.  Local AE ≤ grade 2 (topical) in <30% ","Must be tolerated by 95% of patients.  Would be best to take CTCAE and adapt it to CL, "]
["Efficacy"]
["% complete clinical cure (100% epithelialization) ",{"v":1,"d":"100%"},{"v":0.7,"d":"70%"},"35-50% cure with IL/IM glucantime, NR is some foci "]
["Improved time to clinical cure","100% at D30","70% within 3 months","Natural cure rates 10-20 months"]
["Improved scar formation ","No scar (VSS = 0)","No worse than natural healing","Young female facial highest impact, VSS metric, measure at 6 mo +/-1 mo following end of Rx"]
["Prevention of relapse and recidivans","No relapse or recidivans","< 10% at 1 year","Natural relapse and recidivans rate are about 5-10%"]
["Parasite endpoint needed?","Parasite burden below level of transmission","No","Parasite eradication not possible with current drugs; may not be a good idea in endemic areas, but must be below transmissibility"]
["Administration",null,null,"Must be systemic (oral ROA)"]
["Schedule","Single dose ","Twice daily X 28 days","Self administered, improved compliance with shorter Rx"]
["Supervised Rx (DOT) requirement","No","Yes, minimal ","Best if no DOT required"]
["Route of administration ","Topical / oral / systemic","Non-parenteral or few doses if parentral","few doses of IM/IL drug or IT okay. Parenteral not preferred"]
["Target Population"]
["Age","No restrictions","> 9 moths","With a good safety profile it could be indicated for >9 months  "]
["Gender","No restrictions","No restrictions"]
["Pregnancy","Yes","No","Don't invest in drug with international cat D or E preg rating"]
["Safe to use in co-morbid conditions","Yes","Yes with  common co-morbid conditions","Con med interference?"]
["Efficacious in immunocompromised","Yes","No","No initial testing in this special population"]
["Product Characteristics"]
["Stability","No cold chain, 3 y at 37C","2 years at 4-8C"]
["Drug-drug interactions","None","No testing","Few con-meds"]
["Contraindications","None","Known"]
["Pregnancy","Safe in pregnancy","No known embryo / teratogenicity","Topical easier to prove safe in pregnancy"]
["Regulatory","FDA or EMEA","Single local country registration","WHO essential list?, improves sustainability"]
["Defined regulatory strategy before development","Yes","Yes","defines clinical development and manufacturing path"]
["Orphan drug designation","Yes","Yes","assists registration"]
["Cost"]
["Cost of goods","US$ 3","US$10-30","High cost to encourage production, consider preferantial pricing"]
["Cost to patient / family","< 1$US","< 5$US","Subcidised by governments/Int. org."]
["Indirect (total cost of distribution to point of use)","US$ 5","US$5-20"]
["Preferential pricing possible?","yes","no","Drug available and used for another indication"]
["IP, royalties, licensing entanglements (freedom to operate) analysis","None","Some","To be considered before spending money for doing a trial"]
["Public health impact?"]
[" Transmission blocking","100% blocking","None","Blocking would be ideal for Tx of PKDL & ACL (Primary target of this product)"]
["Sustainability"]
["Drug used for other indication","Yes","No","May stay in market place longer, cheaper, preferential distribution and pricing possible"]
["Are other groups working on the product?","Yes","No","what groups and how much money"]
["Minimal initial budget needed","5M","2M","To initiate some preclinical development on available material, initiate testing of lead compounds from VL strategy and prepare for clinical studies"]

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["ATTRIBUTE","TARGET (IDEAL)","MINIMALLY ACCEPTABLE","COMMENT"]
["Target species","all","single species ","tropica and braziliensis higher priority"]
["species dependent Rx response?","No, one drug treats all","yes","clinical appearance or species dependent dx?"]
["Safety","No deaths, no SAEs","No deaths, no SAEs"]
["medical supervision requried?","none","primary care MOPH","broader access if no med care / supervision needed"]
["Tolerability",null,null,"broader access if well tolerated"]
["CTCAEv3.0","all AES ≤ grade 1","No systemic AE > grade 2. all local AE ≤ grade 2 (topical)","must be better tolerated than SSG"]
["Efficacy"]
["% complete clinical cure (100% epithelialization) ",{"v":0.95,"d":"95%"},{"v":0.5,"d":"50%"},"50% cure with IL/IM glucantime "]
["improved time to clinical cure","95% at D30","50% improvement over natural hx","natural cure rates hard to define"]
["improved scar formation ","no scar (VSS = 0)","no worse than natural healing","young female facial highest impact, VSS metric, measure at 6 mo +/-1 mo following end of Rx"]
["prevention of relapse","no relapse","< 10% at 1 year","natural relapse rate about 10%"]
["parasite endpoint needed?","parasite free","not measured","parasite eradication not possible with current drugs; may not be a good idea in endemic areas"]
["Administration",null,null,"Must be systemic (oral ROA)"]
["Schedule","Single dose","twice daily X 28 days","improved compliance with shorter Rx"]
["suprvised Rx (DOT) required?","no","yes"]
["route of administration","oral / systemic","non-parenteral","few doses of IM/IL drug or IT okay. Parentral not prefered"]
["Target Population"]
["Age","no restictions","> 1 yo"]
["Gender","no restictions","no restrictions"]
["pregnancy","yes","no","don't invest in drug with international cat D or E preg rating"]
["safe to use in co-morbid conditions","yes","not tested","con med interference?"]
["efficacious in immunocompromised","yes","no","no initial testing in this special population"]
["Product Characteristics"]
["stability","no cold chain, 3 y at 37C","no transport cold chain, 2 y at 25C "]
["Drug-drug interactions","None","No testing","few con-meds"]
["Contraindications","none","known"]
["pregnancy","safe in pregnancy","no known embryo / teratogenicity","topical easier to prove safe in pregnancy"]
["Regulatory","FDA or EMEA","single local country registration","WHO essential list?, improves sustainability"]
["defined regulatory strategy before development","yes","Yes","defines clinical development and manufacturing path"]
["orphan drug designation","yes","yes","assists registration"]
["Cost"]
["cost of goods"]
["cost to pateint / family","< 1$US","< 5$US"]
["direct (full cost of final product)"]
["indirect (total cost of distibution to point of use)"]
["preferntial pricing possible?",null,null,"drug available and used for another indication"]
["DnDi development cost (size of investment)?"]
["IP, royalties, licensing entaglements (freedom to operate) analysis","none","some","think about before spending money or doing a trial"]
["Public health impact (transmisson blocking)?","100% blocking","none","PKDL, active CL caused by L. tropica"]
["Sustainabiity"]
["drug used for other indication","yes","No","May stay in market place longer, cheaper, preferential distribution and pricing possible"]

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