Entactex Pharma Research Project, preclinical costs

"Compound GASED° "Estimated "COMMENTS "
" "Cost " "
" "EUR " "
"Medicinal Chemistry " " "
"Patent protection "10,000-20,000"Required for DC nomination "
"Search results (closest prior art) and follow-up plans " " "
"Position paper from Patent dept. " " "
"Critical evaluation of the synthetic procedure including: - "4000 "Required for DC nomination "
"Yields " " "
"Identification of potentially limiting issues e.g. COG, " " "
"FTO of intermediates " " "
"Should be consensus view of TSU and LGCR " " "
"Batch synthesized to support early development "25,000 "Should not stop DC nomination but needs "
"5 – 50 g Available at DC nomination " "to be anticipated as early as possible "
"Dog and Rat tox study, PK studies, preformulation " "Note: - Impact of availability of earlier"
"Material for embro-fetal toxicity studies not included " "tox data (Dog TXP & rat DDO) on timelines"
" " "to FIM needs to be verified- may allow "
" " "earlier dose guidance and hence earlier "
" " "availability of API. "
"LGCR " " "
"Structural characterization "6000 "Required for DC nomination "
"NMR, " " "
"LCMS " " "
"HRMS & MS/MS " " "
"IR " " "
"Single crystal XRD " " "
"Elemental Analysis "200 "Required for DC nomination "
"CHN " " "
"KF " " "
"counterions " " "
"Chemical purity "15,000 "Required for DC nomination "
"RP-HPLC " " "
"Ion exchange chromatography " " "
"SDS-PAGE " " "
"Measured Physico-chemical properties "5000 "Required for DC nomination "
"Molecular Weight " " "
"logP (