merlin8121
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- 18/2/17
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Tenete d'occhio questa LPCN, ha iniziato a muoversi pare.
2017-06-30 Phase 1/2 Clinical Trials LPCN 1021 (oral testosterone replacement therapy) Expects to report topline results during 2Q17 from dosing flexibility (DF) trial evaluating fixed daily dose of 450 mg divided into three equal doses & dosing validation (DV) trial evaluating fixed daily dose of 450 mg divided into two equal doses to support planned 505(b)(2) NDA resubmission in response to JUN16 CRL from FDA citing deficiencies relating to proposed label dosing which was significantly different than dosing in pivotal P3 (SOAR) trial, plans to submit pivotal P3 study protocol w/ SPA request to FDA during 2Q17 for LPCN 1107 which is being developed as an oral twice-daily formulation of an approved steroid drug to prevent preterm birth
Ps: erano il mio prossimo pick, se non avessi avuto la diluzione con anth che mi rallenterà un pò.
https://www.tradingview.com/x/FMHj514h/
2017-06-30 Phase 1/2 Clinical Trials LPCN 1021 (oral testosterone replacement therapy) Expects to report topline results during 2Q17 from dosing flexibility (DF) trial evaluating fixed daily dose of 450 mg divided into three equal doses & dosing validation (DV) trial evaluating fixed daily dose of 450 mg divided into two equal doses to support planned 505(b)(2) NDA resubmission in response to JUN16 CRL from FDA citing deficiencies relating to proposed label dosing which was significantly different than dosing in pivotal P3 (SOAR) trial, plans to submit pivotal P3 study protocol w/ SPA request to FDA during 2Q17 for LPCN 1107 which is being developed as an oral twice-daily formulation of an approved steroid drug to prevent preterm birth
Ps: erano il mio prossimo pick, se non avessi avuto la diluzione con anth che mi rallenterà un pò.
https://www.tradingview.com/x/FMHj514h/
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