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Brucei Rhodesiense Human African Trypanosomiasis (HAT), aka African Sleeping Sickness, for over 100 years Currently only approved in Africa , where PaxMedica has the exclusive license to suramin - treated patient data from key endemic hospitals PAX - 101 received FDA Orphan Drug Designation for this neglected tropical disease in Nov. 2020 NDA Sponsors under this program may qualify for FDA benefits, including a Priority Review Voucher o Market exclusivities up to seven (7) years are also expected to be granted Priority Review Vouchers (PRV) have been be transacted at values > $100 million o PRV Vouchers can potentially be sold to a third party upon receipt following NDA approval PaxMedica intends to file an NDA for the use of PAX - 101 in HAT infections in 2024 8 2022.
PaxMedica will seek accelerated approval for PAX - 101 first in the treatment of HAT under the US Rare Tropical Disease Priority Review Voucher program to gain valuable program incentives . We plan to initiate a pharmacokinetic study to develop additional dosing data in younger / female subjects and plan to submit an IND in 2024 . A global multi - centered clinical trial of PAX - 101 in ASD will commence following US IND approval .
While the Company believes that its internal assumptions are reasonable, no independent source has verified such assumptions . This Presentation contains trademarks, trade names, or service marks belonging to other entities . The Company does not intend the use or display of other parties' trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of, or by these other parties .
Industry publications and third - party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information . The Company's estimates of the patient population with the potential to benefit from treatment with any product candidates the Company may develop include several key assumptions based on its industry knowledge, industry publications and third - party research, which may be based on a small sample size and may fail to accurately reflect the addressable patient population .
Certain information contained in this Presentation relates to or is based on statistical and other industry and market data obtained from independent industry publications and research, surveys and studies conducted by independent third parties as well as the Company's own estimates . The market data used in this Presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data .
Statements contained herein are made as of the date of this Presentation unless stated otherwise, and neither this Presentation shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that the information will be updated or revisited to reflect information that subsequently becomes available or changes occurring after that date hereof .
Given these uncertainties, you should not place undue reliance on these forward - looking statements . The Company qualifies all of the forward - looking statements in this Presentation by these cautionary statements . Except as required by law, the Company undertakes no obligation to publicly update any forward - looking statements, whether as a result of new information, future events or otherwise .
Moreover, the Company operates in a very competitive and rapidly changing environment . New risks emerge from time to time . It is not possible for management to predict all risks, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statements we may make .
Words such as, but not limited to, "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "plan", "potential", "predict", "project", "should", "will", "would" or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes, identify forward - looking statements . These forward - looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Presentation and are subject to risks and uncertainties .