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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/18 ¤U¤È 08:34:21²Ä 594 ½g¦^À³
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Bristol-Myers Squibb Enters into Separate Agreements with Biogen and Roche to License Anti-eTau and Anti-Myostatin Compounds, Respectively http://investor.bms.com/iframes/press-releases/press-release-details/2017/Bristol-Myers-Squibb-Enters-into-Separate-Agreements-with-Biogen-and-Roche-to-License-Anti-eTau-and-Anti-Myostatin-Compounds-Respectively/default.aspx APR 13, 2017 Bristol-Myers Squibb to receive a combined $470M upfront, along with potential milestone payments and tiered double-digit royalties from each company Under the agreement to license BMS-986168, Biogen will pay to Bristol-Myers Squibb an upfront payment of $300 million with potential milestone payments of up to $410 million. Biogen also will assume all remaining obligations to the former stockholders of iPierian, Inc. related to Bristol-Myers Squibb¡¦s acquisition of the company in 2014. Under the agreement to license BMS-986089, Roche will pay to Bristol-Myers Squibb an upfront payment of $170 million with potential milestone payments of up to $205 million. Bristol-Myers Squibb will receive tiered double-digit royalties if either asset is approved and commercialized. These agreements are subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and are expected to close in the second quarter of 2017. |
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·|û¡G«i©¹ª½«e10141841 µoªí®É¶¡:2017/4/17 ¤U¤È 01:32:06²Ä 593 ½g¦^À³
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·PÁº©¹CªÌ¤j¶K¥Xªº³sµ²¡A¸É¤W¸Ó³sµ²¸Ì¥¼¥Z¥Xªº¨â¬q¡A¤]´N¬OPharma Boardroom ¸Ìªº³Ì«á¨â¬q³X°Ý ¥¼¨Ó±z»{¬°¤ß®®¥ÍÂå³Ì«nªº¦¨¥\¦]¯À¬O¤°»ò¡H ÀHµÛ¥¼¨Ó´X¦~§Ú̱N³°Äò¶}©l¤CÓ·sÃIJ£«~½uªº±ß´ÁÁ{§É¸ÕÅç¡A§Ú̪º²£«~ÀH®É·Ç³Æ¶i¤J¥«³õ¡A¦Ó§ÚÌ¥Dnªº¥«³õ«ÜÅãµMªº«K¬O¬ü°ê¡B¼Ú·ù¡B¤¤°ê¡C¦Ò¶q¨ì¥xÆWªº¥«³õ³W¼Ò¤j¤p¡A¹ï©ó¤@Ó®Ú¦b¥xÆWªº¤½¥qn¬¡ÅD©ó¥þ²y»R¥x¤W¡G¶Õ¥²³z¹L¦¬ÁÊ (acquisition)¡B±ÂÅv¨óij(licensing agreement)¡Bµ¦²¤¦X§@¹Ù¦ñ (strategic partnerships) µ¥¤è¦¡¡C ¬ì¾Ç¬ã¨s¬O§Ú̪º°ò¦¡A¦ý¨¬°¤@Ó¥xÆW¤½¥q±N§ÚÌ°Ó·~¼Ò¦¡ªº¯à¤O¥þ²y¤Æ¬O§ó«nªº¯à¤O¡C³o¥²¶·n¾ã¦X¥þ²yªº¸ê·½¤~¯à¦P®É°õ¦æ¤£¦PÃþ«¬ÃĪ«ªº¥þ²y¦h¹êÅ礤¤ß¤T´ÁÁ{§É¸ÕÅç¡C¦pªG¥u§ä©e°U¬ã¨s¾÷ºc (Contract Research Organization, CRO) ¥N¬°¬ãµo¨ã¬D¾Ô©Êªº¸ÕÅç¡A«D±`¦³¥i¯à¥Ã»·µLªkÀò±o¦Û¤v¹w·Qªº¦¨ªG¡C§ÚÓ¤H¤§«e¿Ë¦Û³]p¡A²{¦b«h¿Ë¦ÛºÊ·þ©Ò¦³§Ú̪º¸ÕÅç¡C§Ú¬Û«H¦pn§â³Ð·sªºÃıa¤J¥þ²y¥«³õ¡A¦¨¥\ªºÃöÁä«K¬O°õ¦æ¤Oªº«~½è¡C¦b³oÓ¶¥¬q¡AµLÃö¬ì¾Ç¬ã¨s¡A¦Ó¬On¦³¯à¤O³Ð³yÀô¹Ò§â¬ì¾Ç¬ã¨sªº¦¨ªG¨ãÅé¦a§e²{µ¹¥X¨Ó¡C ±z¹ï¤ß®®¥ÍÂåµo®iªºÄ@´º¬°¦ó¡H §Ú֦̾³³»¦yªº¬ì¾Ç®a¡A¤]±N¦b¤¦~¤º¦¨¬°¥@¬É¯Åªº¤¤¼Ï¯«¸g¨t²Î¯e¯f·sÃĬãµo¤½¥q¡C¦pªG§Ú̱o¨ì¬ð¯}©ÊÀøªk»{©wªº¨âÓ·sÃĶ¶§Q¤W¥«¡A«K¯à¥ß§Y¦b¬ÛÃö²£·~°é¤Î³W½d¨î©wªÌ (regulatory stakeholders) ¤¤¦û¦³¤@®u¤§¦a¡C¦b¤¤¼Ï¯«¸g¨t²Î¯e¯fªº¬ÛÃö»â°ì¤¤¡AÄvª§¯S§O¤Ö¡AÁöµM¦³30% ªº«·s©w¦ìÃĪ« (repositioned drug) ¦bªvÀø¦¹Ãþ¯e¯f¡A¦ý©úÅã¯Ê¤Ö³Ð·sªº«ªvÀø¤èªk¡C¦Ó¥B¦pªG§Aª¾¹D¥Ø«e¦b¬ü°ê¦³70% ªº¤¤¼Ï¯«¸g¨t²Î¯e¯fÃĪ«¤´¬O¥é³æ¼Ð¥Ü¥~¨Ï¥Î (off-label use) ¡A§Ú̪ºªvÀø¤èªk²@µLºÃ°Ýªºµ´¹ï·|¦b¥«³õ¤W¦³·¥¨Îªº«e´º¡C §Ú̪º©w¦ì©M¥ø¹Ï«D±`©ú½T¡G¤ß®®¥ÍÂå¬O¤@®a¬ì¾Ç¬ã¨s«¬ªº¤½¥q¡A»EµJ¦b°ª«×¼vÅT¤Oªº²©R©Ê³Ð·sÀøªk¡A³o±N³yºÖ¯f¤H¤Î¨ä®aÄÝ¡C§Ú¬O¤@ÓÂå¥Í¡A§Úºn¤]³Ì«nªº¥Ø¼Ð¡A´N¬O´À¯f¤H°µ¦nÀ³°µªº¨Æ¡A¨ä¾lªº¦ÛµM·|ÀH¤§¦Ó¨Ó¡C |
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·|û¡Gº©¹CªÌ10144096 µoªí®É¶¡:2017/4/17 ¤U¤È 12:27:02²Ä 592 ½g¦^À³
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www.most.gov.tw/la/ch/detail?article_uid=0c39a4b5-2065-11e7-bed9-005056826649&menu_id=2f9e8a7e-65a8-4a6b-a202-eea9c75350ca ³o¬O¬ì§Þ³¡¾n¬¥§üÁF¥x¥_¸gÀÙ¤å¤Æ¿ì¨Æ³B¬ì§Þ²Õªº±MÃD¤å³¹ ¬Ý°_¨Ó¹³¬O3/29 ¥Zµn¦bPharma Boardroom ªº½²±Ð±Â±M³X¤¤Ä¶¡A¨Ñ¤j®a°Ñ¦Ò |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/16 ¤U¤È 08:01:10²Ä 591 ½g¦^À³
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9.2.3.2 The standardized mean difference http://handbook.cochrane.org/chapter_9/9_2_3_2_the_standardized_mean_difference.htm ¡u Effect sizes typically, though not always, refer to versions of the standardized mean difference. ¡v |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/16 ¤U¤È 02:22:22²Ä 590 ½g¦^À³
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http://terms.naer.edu.tw/detail/1308366/ ®ÄÀ³¤j¤p Effect Size ±i¤l¶W 2000¦~12¤ë ±Ð¨|¤jÃã®Ñ ¦Wµü¸ÑÄÀ:¡@¡@¦b¡u«á³]¤ÀªR¡v(meta-analysis)ªº¬ã¨s¤¤¡A®ÄÀ³¤j¤p¤Î²ÎpÅãµÛ©Ê¬O¨âÓ±´¨sªº«n¶µ¥Ø¡C¦³Ãö«á³]¤ÀªR¬ã¨sªº·N¸q¡A½Ð°Ñ¨£¡u¶qªº¡]©w¶q¡^ºî½×¡v¡C©Ò¿×®ÄÀ³¤j¤p¬O«ü¦b«á³]¤ÀªRªº¬ã¨s¹Lµ{¤W¡A©Ò¤ÀªRªº¨C¤@Ó¬ã¨sªº¹êÅç³B²z®ÄÀ³ªº¤j¤p¡A¤]´N¬O¨C¤@Ó¹êÅç³]p¤¤±µ¨ü¹êÅç³B²zªº¹êÅç²Õ»P±±¨î²Õ¤§¶¡ªº®t§O¡C¬°¤F²Îp³B²z¡A³o¨Ç¹êÅç³B²zµ²ªGªº®t§O»Ý¥ý¸g¹L¼Ð·Ç¤Æªº³B²z¡A¤~¯à¶i¦æ¤ñ¸û»P¦Xp¡C©Ò¿×¼Ð·Ç¤Æªº³B²z´N¬O§â¹êÅç³B²zªº¹êÅç²Õ»P±±¨î²Õ¤§¶¡ªº®t§O°£¥H±±¨î²Õªº¼Ð·Ç®t(standard devia-tion)¡C ¡@¡@®ÄÀ³¤j¤pªºÈ¥i¥H¥Nªí´N¬Y¤@¶µ¬ã¨s¥DÃD¦Ó¨¥¡A¹êÅç²Õ©M±±¨î²Õ¤§¶¡®t²§ªº¤j¤p¡AÈ·U¤j¡A¥Nªí¹êÅç³B²zªº¥\®Ä·U¤j¡FÈ·U¤p¡A¥Nªí¹êÅç³B²zªº¥\®Ä·U¤p¡C |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/16 ¤U¤È 02:00:12²Ä 589 ½g¦^À³
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¡ua small SMD for a fatal disease is more important than a large SMD for a transitory rash. ¡v ¡uEffect sizes of general medicine medication are presented on the left-hand side (median 0.37, mean 0.45, 95% CI 0.37¡V0.53) and psychiatric drugs on the right-hand side (median 0.41, mean 0.49,95% CI 0.41¡V0.57).¡v ³o¨â¬q¸ÜÅý§Ú·Q°_¤ß®®NaBenªºeffect size Áö»¡nµ¥¨ìÁ{§Éµ²§ô¤~·|ª¾¹D ¦ý¥H¥ý«eªº¸ê®Æ¡]½Ð°Ñ¦Ò¦Ñ¥v¤j¤jªº¹q¤l³ø¡^¡A©Îµy¥i§PÂ_¥¦ªºÃÄ®Ä ¶È¨Ñ°Ñ¦Ò , ÁÂÁ¤j®a! |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/16 ¤U¤È 01:16:37²Ä 588 ½g¦^À³
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Putting the efficacy of psychiatric and general medicine medication into perspective: review of meta-analyses http://www.antoniocasella.eu/archipsy/Leucht_2012.pdf ¤µ¤Ñ¬Ý¨ì³o½g¤å³¹¬O¼gÃĪ«ªº®ÄªG ¤p§Ì¸g±`¦b·Q effect size ¦h¤j¤~¥s¦n? ©Î³\¦³³\¦h¤j¤j»P§Ú¦³¬Û¦PªººÃ°Ý , ©Ò¥H¶K¤å½Ð¤j®a°Ñ¦Ò ¦³¤H§âeffect size¥Î0.3 »P alpha = 0.05 ,powerÈ = 0.80 §@¿Å¶q¼Ð·Ç µM¤µ¤Ñ³o¤å³¹¸Ñµª¤F¤p§Ìªº°ÝÃD ¤å¤¤¼g¹D "Cohen¡¦s rule that an SMD of 0.2 is a small effect size, 0.5 medium and 0.8 a large effect size is often used, but Cohen hastened to say that the interpretation depends on the context; a small SMD for a fatal disease is more important than a large SMD for a transitory rash. " ¤S±q Fig. 1 Summary of effect sizes , ¥i¬Ý¨ìÃÄ«~effect sizeȪº¤À¥¬ Effect sizes of general medicine medication are presented on the left-hand side (median 0.37, mean 0.45, 95% CI 0.37¡V0.53) and psychiatric drugs on the right-hand side (median 0.41, mean 0.49,95% CI 0.41¡V0.57). ¤]³\±q¹Ï1ªº³oÓ»¡©ú¤¤ , ©Î¥i¤F¸ÑÃĪ«effect sizeȪºÁͦV ¤p§Ì¥u«Cµæ¬Ý¤@¬Ý , ÁٽХý¶iÌ«ü¥¿»P¸É¥R ¶È¨Ñ°Ñ¦Ò , ÁÂÁ¤j®a! |
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·|û¡G«i©¹ª½«e10141841 µoªí®É¶¡:2017/4/14 ¤U¤È 07:20:02²Ä 587 ½g¦^À³
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Pharma Broadroom ½Ķ Part 2 Q: ÁöµM¥H¤¤¼Ï¯«¸g»â°ì¦Ó¨¥¬O¬Û·í¯S§O¤Ö¨£ªº¡A±zªº¨âÓ²£«~ (SND 13 ¤Î SND 12¡AªvÀøºë¯«¤Àµõ¯g (schizophrenia) ) ¤À§O¦b2014¦~12¤ë¤Î2015¦~11¤ë±o¨ì¬ü°ê¹«~»PÃĪ«ºÞ²z§½ªº¬ð¯}©ÊÀøªk»{©w¡C±z²{¦b¤]p¹º±N±j¤ÆNMDAªºÀøªkÀ³¥Î¦b§ó¼sªxªº¸£¥¢½Õªº¯e¯f¡C±z¯à§_·§²¤¤¶²Ð±j¤ÆNMDAÀøªkªº¾÷Âà¡A¦Ó¬°¦ó¹ïªvÀø¤¤¼Ï¯«¸g¨t²Î¯e¯f¦p¦¹¦³®Ä¡H A: ±q¬Y¤è±¨Ó»¡¡ANMDA ªº½Õ±±¾÷Âà¥i¥H³Qµø¬°«Øºc¦b¤j¸£ªº¤À¤l°ò¦¤W¡CÁ|¨Ò¦Ó¨¥¡A¦pªG°±¤î¬YÓÓÅ骺NMDA¨t²Î¡]deactivating¡^¡A¥L«K·|³à¥¢°O¾Ð¡A¡A¦Ó¥B·|§¹¥þ«ÊÂê¸Ó¤j¸£¾Ç²ß»PÄ~Äòµo®iªº¯à¤O¡A¬Æ¦Ü¯«¸g²ÓM·|¶}©l¦º¤`¡CÁ`Åé¨Ó»¡¡ANMDA¨t²Î¦b¯«¸g¬¡°Ê¤¤§êºt°ò¥»ªº¨¤¦â¡G80% ªº¬ðIJ§Q¥Î¨¦®ò»Ä (glutamic acids) ¨Ó¶Ç»¼°T¸¹¡A¦Ó¥¦(¨¦®ò»Ä)ªº¨üÅé (receptors) ¤j³¡¤À´N¬O¦bNMDA¨t²Î¡C ®Ú¾Ú§Ú̱o¨ìªºÃÒ¾ÚÅã¥Ü¡A«Ê³¬NMDA¨t²Î·|¨Ï¯f¤H«äı¥¢½Õ (psychotic)¡C1990¦~¥N«á´Á§Ú´N¹w´ú: ¤Ï¤§¨Ó±j¤ÆNMDA¨t²Î©Î³\¥i¥HªvÀø«äı¥¢½Õ¡C·í§â±j¤ÆNMDA§@¬°§Ú¤§«e´£¹LªºÂàĶÂå¾Ç¹êÅç®É¡A§Úµo²{«äı¥¢½Õªº±wªÌ¼~Æ{ªºª¬ªp¤]§ïµ½¤F¡C §ó¶i¤@¨Bªº¬ã¨s¤§«áÃÒ¹ê¤F¼~Æ{¯g»P¦Û±þ¶É¦Vªº®Ú¥»¾÷Âà¡A¦Ó³oÓ¹ï¼~Æ{¯g¥¿±ªºµ²ªG¨Ã¤£¥u·½¦Û©ó±wªÌ«äı¥¢½Õªº§ïµ½¡C ÁöµM³oÓ¾÷¨îÃþ¦ü¦Ê¼~¸Ñ (Prozac)ªº¾÷Âà ¡A¦ý¬O§Ú̲£«~ªºÁ{§É¹êÅçµ²ªG¬O¯à¶W¹L¨â¿¥H¤W½w¸Ñ²v (remission rates)¡A¦P®É¯àÅãµÛ¦a°§C¯f¤Hªº¦Û±þ·N©À¡C¦]¦¹¡A§ÚÌ¥¿¦b¬°³oÓ¦³¾÷·|¦¨¬°¦³¥v¥H¨Ó²Ä¤@ӧܦ۱þÃĪ«³]p¤T´ÁªºÁ{§É¸ÕÅçpµe¡C «ÝÄò...... |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/13 ¤U¤È 06:58:19²Ä 586 ½g¦^À³
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¦Ñ¥v¤j¤jªº¹q¤l®Ñ´I§tª¾ÃѪºª÷»È°]Ä_¡A©Î³\¤]ÄÂõۯu¥¿ªºª÷»È°]Ä_ NaBen(¶uf)³oӤ߮®ªº·sÃÄ¡A¤p§Ì¤µ¤Ñ¤~ª¾¹D¥¦¦³µÛf¥Ò»Ä¶u ( Sodium benzoate¡ANaC6H5CO2)ªºÁY¼v ¦Ñ¥v¤j¤jªº¹q¤l®Ñ®Ç¼x³Õ¤Þ¡BIJÃþ®Ç³q¡A¥O¤HÃø¥H±æ¨ä¶µI ¸òµÛ¦Ñ¥v¤j¤jªº¸}¨B ¡A·j´M¤Þ¥Î®Ú·½ ¡A¦b³oµ¥«Ýªº·í¨à¡A¦Û¦³¨ä¼Ö °ß½²±Ð±Âªº½×¤å¦Û»{µLªk²z¸Ñ ¡A¤D©ñ±ó·j´M ¯÷¤Þ´X³Bºô§}¡A¨Ñ¤Íµ¥°Ñ¦Ò Åý¤ß®®®³¨ìFDA BTDªº½×¤å¼Æ¾Ú http://jamanetwork.com/journals/jamapsychiatry/fullarticle/1746121 http://www.cadencetrials.com/sites/default/files/pdf/Lane2013.pdf 2015/4/24 FDA¬ã°Q·|¡¨Breakthrough Therapy Designation: Exploring the Qualifying Criteria¡¨¤Û¿O¤ù https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM447162.pdf NaBen ªº¤¶²Ð¦bS103 ~ S111 ½²±Ð±ÂÀòÁÜ°Ñ¥[¬ã°Q·|ªº¦Û«H¤¥ªö (¬ù¦b9¤À ~ ¡F45¤À ~ ¡F 58¤À ~ ) https://www.youtube.com/watch?v=pEpUoj2rfoo ¥t¥~ P¡®¢â Community ªº New Schizophrenia Treatments Address Unmet Clinical Needs https://www.ptcommunity.com/journal/article/full/2017/2/130/new-schizophrenia-treatments-address-unmet-clinical-needs ¤¶²Ð´XºØºë¯«¤Àµõ¦b¸ÕÅ礤ªº·sÃÄ ¨ä¤¤Ãö©ó¤ß®®NaBen NaBen (sodium benzoate, SyneuRx International [Taiwan] Corp.) is a D-amino acid oxidase inhibitor under clinical development as a schizophrenia treatment.6 It was granted orphan drug status for the treatment of schizophrenia patients with refractory disease in combination with clozapine in December 2011 and for the treatment of schizophrenia in pediatric patients in July 2012.41 In December 2014, NaBen also won a breakthrough therapy designation as an adjunctive treatment for schizophrenia in adults. A phase 2, randomized, double-blind, placebo-controlled trial was conducted in Taiwan to determine the clinical and cognitive efficacy of add-on treatment with sodium benzoate in patients with schizophrenia who had been stabilized with antipsychotic medications for at least three months. Fifty-two patients received six weeks of add-on treatment with 1 g daily of sodium benzoate or placebo. Sodium benzoate was associated with a 21% improvement in the PANSS total score compared with placebo. Significantly greater improvements were also observed in Scales for the Assessment of Negative Symptoms¡V20 items, the Global Assessment of Function, the Quality of Life Scale, and the Clinical Global Impression in patients receiving add-on sodium benzoate treatment compared with placebo treatment. SyneuRx filed a proposed phase 2b/3 study of sodium benzoate with the National Institutes of Health in September 2014, but as of December 2016, no subjects have been recruited. The multicenter, prospective, randomized, placebo-controlled, sequential parallel comparison design trial is expected to enroll an estimated 240 adults with schizophrenia. The study will consist of a 19-week double-blind phase followed by a 26-week open-label extension phase. ³Ì«á¤@¬q¤ß®®¤w¸g°µ¤FÅܧó ¡A¨Ã©ó2017/4/6¶}©l©Û¶Ò±wªÌ In summary, several products are being developed to address the significant unmet needs that exist in the schizophrenia marketplace. For example, three potential treatments¡XITI-007 (Intra-Cellular Therapies), MIN-101 (Minerva Neurosciences), and NaBen (SyneuRx)¡Xare aimed at managing the negative symptoms of the disease¡K¡K. Á`µ²¤¤°w¹ït©Ê¯gª¬ªºÃÄ ¡A °£¤FNaBen ¡AÁÙ¦³ITI-007¡B MIN-101 ITI-007: http://ir.intracellulartherapies.com/releasedetail.cfm?releaseid=991333 MIN-101: http://www.minervaneurosciences.com/innovation-pipeline/min-101/ effect size³£¨S«Ü¬ð¥X ¦Ñ¥v¤j¤jªº¥Î¤ß»P§V¤O ¤j®a³£¬Ý±o¨£ ¯u¬O¤Ó·PÁ¤F ¤]ÁÂÁ¤j®a ¹ï©ó«i©¹ª½«e¤jªº¼ö¤ß½Ķ ¡AªA°È¤j®a ¡A¤p§Ì¤]P¤WÁ·N |
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·|û¡G«i©¹ª½«e10141841 µoªí®É¶¡:2017/4/12 ¤U¤È 03:27:27²Ä 585 ½g¦^À³
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¦³ÃöT^T¥Sªº¤TÂI¡A§Ú²³æ·Qªk¦p¤U 1.SND13ªºAdd-on´N¬OÃþ¦üIDOi»PPD-1¡BPD-L1ªºAdd-on¡A³o¦bºë¯«¬ì¨Ã¤£¯S§O¡A¼~Æ{¯gRapastinelªºP3¤]¬O³o¼Ë³]p¡A¦ýSND12¬O§â¤@Áûapprovalªºclozapine©M¤@ÁûÁ{§É¤¤ªºf¥Ò»Ä¶u¡u¥´¦¨¤@¿õ¡v¡A¤£ª¾Incyte©Î¬ONewlink¤fªAªºIDOi¬O§_¤w©MIVªºPD-1¡BPD-L1¡u¥´¦¨¤@¿õ¡v¡H 2.·sÃĪѱ`¥Îªºµû»ù¤èªk¬O¦P·~¤ñ¸ûªk©ÎDCF¤ÀªR¡A¦¬®×©µ½wªº®É¶¡¦]¤l¥i³z¹LDCF¼Ò«¬¦X²z§é»ù¡CªÑ»ù¤U¶^ì¦]¿ùºî½ÆÂø¡Aɥαбªº¤å³¹¡u¥xÆW¥Í§Þ²£·~°ª«×Â\Àúªº°Êª«©Ê¡v¡A¦³¨âÓBTDªº¥«È¿éµ¹¸Ñª¼¥¢±Ñªº¡A¿éµ¹¥Íª«¬Û¦üÃĪº¡A¦b³o¤£°Q½×ªÑ»ù¡A¦ýirrational behaviorªº§ë¸ê¦æ¬°¬O«Ü¦³½ìªº¸ÜÃD¡C¶¶¹D¤@´£¡A§Ú«D±`³ßÅw±Ð±Â»¡ªº¡GIf you content yourself with delegating a CRO to conduct challenging trials on your behalf, it is very likely that you will never get the results you envisioned. I personally designed and now supervise all our trials, because I believe that when it comes to bringing an innovative drug onto the global market, the main success factor is the quality of execution. At this stage, it is not about science any longer, but about being able to build the conditions that will clearly showcase the scientific outcomes that you have identified.¡A¬°¦¹©µ½w¡A§Úı±oȱo°Õ¡A³£¨«¨ì³Ì«n¤@¨B¤F 3.IA¨Ã¤£¬O¹³°ò¨È¨º¼Ëªº´Á¤¤¤ÀªR¡A¥u¬O³æ¯Â¬Ýresponderªº¤H¼Æ°÷¤£°÷¡A»Ý¤£»Ýn¥[¦¬¨ü¸ÕªÌ¦Ó¤w¡A¡u¤£¬O¸Ñª¼¡v¡A¨S¦³¶}µPªº°ÝÃD |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/7 ¤U¤È 09:39:14²Ä 573 ½g¦^À³
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Cliff¤j®¦¼wªº¤j¤åµo¤H²`¬Ù ¤p§Ì«o¦b¤T¤Ñ«á¤~²¤²¤·P¨ü¨º¤@¬q¤å¦r ¡uSND-13ªºphase II/III¸ÕÅç³]pȱo¬ã¨s¡A«Øij¦h¬ã¨sÃöª`¡C¨Ò¦p¥¦¥Î¤F»ò¤è¦¡ªº³]pÅýFDA«HªA¥i¥H®ø°£¬Û·íªº¦w¼¢¾¯®ÄÀ³¡v ¤£¸TÆg¹Ä½²±Ð±Âªº¥Î¤ß©M¿Ë¤O¿Ë¬° ¦nÁo©ú¤S¯S§Oªº³]p¡A¬Ý¤F´Nª¾¹DÅo¡I Detailed Description: This is an adaptive, phase IIb/III, multi-center, prospective, randomized, placebo-controlled study, in which adult subjects with schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a 4 week run-in part, and 8 week double-blind treatment part, and a 52 week Open-Label Extension part. Screening part of the study: The subjects will be evaluated for eligibility during the Screening part of the study. Enrichment run-in part of the study: Subjects who are determined to be eligible will enter the Run-in part of the study. A total of 348 Subjects will be randomized. The randomized subjects will receive 4 weeks of NaBenR or Placebo accordingly. The subjects who have completed 4 weeks of randomized treatment in both groups (NaBenR or Placebo) will be assessed and categorized intoresponders and non-responders, based on 20% or more reduction from baseline in their PANSS total scores as per the evaluations at Visit 2 and Visit 4. Double-Blind treatment part of the study : Subjects who have successfully completed the Enrichment Run-in part will enter the Double- Blind treatment part of the study per below: NaBenR treated subjects: Subjects will continue receiving NaBenR for another 8 weeks. Placebo treated subjects: Placebo Responders: Subjects will continue receiving Placebo for another 8 weeks. Placebo Non-responders: Subjects will be re-randomized to receive NaBenR or Placebo in a 1:1 ratio for another 8 weeks. Open-Label Extension part of the study: All subjects who have completed the Double-Blind part of the study will continue with the Open-Label Extension part of the study to receive NaBenR for an additional 52 weeks, plus a 2 week follow-up. |
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·|û¡GT^T10142245 µoªí®É¶¡:2017/4/4 ¤U¤È 11:29:18²Ä 572 ½g¦^À³
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1. add-onªvÀø¤£¤@©wn¬OapprovalªºÃĪ«¡A¤£µM²{¦bI/O¨Ö¥Î¤@¤j°ïÃĪ«(IDOi ...)´NGG¤F! clinicaltrials.gov/ct2/results?term=syneurx&Search=Search 2. ¦p¤WCTºô¯¸¡ASND111¦¬®×¤¤¡A 112 & 113³£ÁÙ¨S¶}©l¦¬®×¡A¥u¯à»¡¶i«×¤ÓºC¤F¡AªÑ»ù·íµM¤U¶^¡A®É¶¡¹ï·sÃĪѬO«Ü«nªºÄ³ÃD¡C 3. ¤£ª¾¹DSND111ªº¶i«×¡A¨ÌCT¤Wªº³]p¡A IA¦b¦¬®×76¤H«áµo¥Í¡A³oÀ³¸Ó¬O³Ìªñ¥i¯à¼vÅTªÑ»ùªº¥²n¨Æ¥ó¡C À³¸Ó¤ñ 112©Î113§Ö§a! ®É¶¡©ì¶V¤[¡A¿N¿ú¶V¦h¡AªÑ»ù¤U¶^«Ü¦X²z°Ú! |
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·|û¡GABC10134671 µoªí®É¶¡:2017/4/4 ¤U¤È 06:42:17²Ä 571 ½g¦^À³
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·|û¡GCliff10135274 µoªí®É¶¡:2017/4/4 ¤U¤È 05:59:58²Ä 570 ½g¦^À³
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¥v¤j¤j´£¨ì¡uSND-12¬OFDA°eªº¤j§¡v¡A¦ó¥HP¤§¡H ¥h¦~ªÑªF·|«á½²¸³§Y®u¤S°µ¤F¤@¤p¬qªºÁ¿ºt¡A´£¨ìSND-12¬O°w¹ï¤w¸g¨Ï¥Î³Ì«á¤@½uÃĪ«¡]´N¬OClozapine¡^ªº±wªÌ¡A¥[¤WNaben°µ¦X¨ÖªvÀø¡C ³oÓ¬ãµo¤¤·sÃÄ®³¨ì¤F¨âÓ»{ÃÒ¡G¬ð¯}©ÊªvÀø»P©t¨àÃÄ»{ÃÒ¡C ¥L´£¨ì¡G 1.ªk³W¤W¦X¨ÖªvÀøªº¨âºØÃĪ«¡A¥²¶·¬O¨âÓ³£¤w¸g¬OÃĪ«¤F¤~¨Ó½Í¦X¨ÖªvÀøªºÀø®Ä¬O§_Àu©ó¦U§O¨Ï¥ÎªºÀø®Ä¡FµM¦Ó³oNaben¤´¬°¬ãµo¤¤·sÃÄ¡A°ò¥»¤W¬O·Q³£§O·Q¡A¦ý½²¸³»{¬°¤w¸g¥Î¨ì³Ì«á¤@½uªºclozapine¡AY®³±¼clozapine¥i¯à·|¦³·ÀI¡F¦Ó¥BÁöµM¬O¥[¤W¥h°µ¸ÕÅç¬ÝÀø®Ä¡A¦ý¥H«á¥X¨Ó®É¬O¤@Ó¦X¨ÖªºÃÄ¡A¤º§t¨âºØ¦¨¤À¡]´N¬O¥v¤j¤j»¡ªº¡u¥´¦¨¤@¿õ¡v¡F³o¸ò¥i¥[¤]¥i¤£¥[ªºadd-on¥[¦¨ªvÀø·N¸q¤j¤£¬Û¦P¡^¡A¿×¤§¦X¨ÖªvÀø¡C½²¸³»¡¡A»P·|ªºFDA©xû§ì§ìÀY»¡¡A§ÚÌ¥i¯à·|ã§A¡K¡K ©Ò¥H¥i¥H¥h·Q¹³¡A¬Æ»òÃĬƻòÅÞ¿è¬Æ»òÃÒ¾Ú¥i¥H»¡ªAFDA©xû·ÓµÛ¦Û¤v³]pªºÁ{§É¸ÕÅ稫¡H¤£¥~¥GÃĪ«¦w¥þ©Ê¡BÀø®Ä¡]nÀu©ó²{¦³ªvÀø¡^¡BÁ{§É¸ÕÅç³]pn²Å¦XÅÞ¿è»Pªk³W¡K¡K³o¨Ç³£»Ýn¨Æ¥ý¿¦±Kªº«ä¦Ò¡A¥L°µ¨ì¤F¡C ¦Ó¬ð¯}©ÊªvÀø»{ÃÒ¡A»Ýº¡¨¬¨ã¦³¤HÅ骺ªì¨B¼Æ¾Ú¡A¥BÀu©ó²{¦³ªvÀø¡C¦ý¬O¦b³oÓ¯e¯fªºªvÀø»â°ìùØ¡A¨Ã¥¼¦³¥[¦¨©Î¦X¨ÖªvÀøªº²Õ¦X¡]µù1¡^¡A©Ò¥HµLÃÄ¥i¤ñ¡A¥un¯à´£¥Xclinical significant¼Æ¾Ú¡A´N¯à®³¨ìBTD¡C¡]µù2¡^ 2.쥻½²¸³¥Ó½Ðªº¬OSND-12¥Î©ó¡usuper¡vrefractory schizophreniaªº©t¨àÃÄ»{ÃÒ¡A¤]´N¬O¹ï³Ì«á¤@½uclozapineµL®Äªº±wªÌ¨Ó¥Ó½Ðªº¡FY§ârefractory schizophrenia¡]¥¿¦b¨Ï¥ÎclozapineªÌ¡^¤]¯Ç¤J¡A«h·|¶W¹L20¸U¤H¦Ó¤£²Å¦X©t¨àÃÄ»{ÃÒ±ø¥ó¡A¦ý³Ì«áFDA¡u³º¡v¦P·N¥un¤w¥Î¨ì³Ì«á¤@½uªºclozapineªº±wªÌ¬Ò¥i¯Ç¤J¡A³o²ª½Ãø¥H·Q¹³¡A¬Æ»òÃĬƻòÅÞ¿è¬Æ»òÃÒ¾Ú¥i¥HÅýFDA©xû¦p¦¹¬X³n¡K¡K¡C¦p¦¹¤@¨Ó¤£¶È¥iÁקK¥u¯Ç¤J¹ïclozapineµL®Ä±Ú¸s¹L¤Ö¦ÓÃø¥H¶i¦æ¦¬®×¡A§ó«nªº¬O¥un¤wªA¥ÎclozapineªÌ¬Ò¥i¦¬®×¡A¹F¼Ð«á¬Ò¥i°µ¬°¥¦ªº¾AÀ³¯g¹ï¶H¡A¥«³õÂX¤j¡C ¤ß®®ªº¬G¨ÆÁÙ¦³«Ü¦h¬O¥O¤HÃø¥H·Q¹³ªº¡A²£«~½uÀH«K¤@§ì¦Ü¤Ö´N¦³¤»Ó¬O·s¾÷Âà¡A³o¤TÓ¦r¬O¦Û¤v¥i¥H³Û²nªº¶Ü¡HÁÙ¦³¥ý«e²³©Ò©Pª¾ªº¡u¥h¥«³õ·Q¶R¤@ÓÄ«ªG¡A«o·N¥~¦a©ê¦^¤@Ó¤j¦è¥Ê¡C¡vµ¥µ¥¡A¤£¬O¨S®Æ¡A¦Ó¬O¥~¬É¤´µMÃúùجݪá¡Aµ¥§A¬ÝÀ´´N¡K¡K¡CÁÙ¦³¨º½g¡u¯ª¥À©w«ß¡v¤]¬O³ôºÙ¤@µ´¡F¡u®ü¤ý¬P³Qµo²{ªº¾ú¥v¡v¡K¡K¡A¤£¤UÂI¥\¤Ò°µ¬ã¨s¡A«ÜÃø¿s¨ä°ó¶ø¡C¥v¤j¤j¬°¦ó¬°¥¦ªºªÑ»ù©ê¤£¥¡H²³æªº»¡¡A´N¬OÁà¤pÀn©Î¦Ç©h®Q¬G¨ÆªºÂ½ª©¡A«Åª³o¨Ç¤p®ÉÔªº¬G¨Æ·|¦³¤£¦PªºÅé·|¡C SND-13®³¨ìBTD¤w¸g¤@¦~¤F¡A¤µ¦~3¤ë©³¤~¶}©l¦¬®×°µphase II/III¡Aªá¤F³o»òªøªº®É¶¡³£¨S°ÊÀR¡A¤@©w¬O°µ¤£¥X¨Ó¡F¸³¨Æ³¯¥¿¥ý¥Í»P°ÆÁ`¸g²z³¯ÂEºa¥ý¥Í¬ÛÄ~Â÷¾¡A³o®a¤½¥q¤º³¡¤@©w¥X¤F°ÝÃD¡Fºë¯«¬ìÃĪ«¦³¦w¼¢¾¯®ÄÀ³¡A¨S¨º»ò®e©ö¹F¼Ð¡Fn¦YNaben©Îsarcosine¥i¥H¦Û¤v¥hºô¸ôÁʶR°·±d¹«~´N¦³¤F¡K¡K¡A³o¨Ç³£¬O·í«e¥~¬É¹ï¥¦ªº²Ê²L¬Ýªk¡A§Ú»{¬°¤¤¼Ï¯«¸g»â°ìªº¤º®e¡A쥻´N¶W¶V¤@¯ë¤Hªº¤F¸Ñ¡A¦pªG¨Sªá¤@¯ë¥\¤Ò¥h°µ¤F¸Ñ´N»{¬°¥¦¤£·|¦¨¥\¡A®£©È¦³¬Û·íªº¿ò¯]¤§¾Ñ¡C SND-13ªºphase II/III¸ÕÅç³]pȱo¬ã¨s¡A«Øij¦h¬ã¨sÃöª`¡C¨Ò¦p¥¦¥Î¤F»ò¤è¦¡ªº³]pÅýFDA«HªA¥i¥H®ø°£¬Û·íªº¦w¼¢¾¯®ÄÀ³¡]¤åÄm¤W»¡ºë¯«¬ìÃĪ«¸ÕÅ窺¦w¼¢¾¯®ÄÀ³¥i°ª¹F50¢H¤§¦h¡^¡F¬°¦ó¦¬®×±ø¥ó»Ý±Æ°£´¿¸g¨Ï¥Î©Î¥¿¦b¨Ï¥ÎclozapineªÌ¡H¡]±À´ú¬O§â¥¿¦b¨Ï¥Îclozapine±wªÌ¼·¥hSND-12¸ÕÅç¥h¤F¡^¡C¡]°ò©ó®Ä²vªº¦Ò¶q¡ASND-12¸òSND-13¬O¦P®É°õ¦æªº¡^ µù¡G 1.¼~Æ{¯gªºªvÀø´N¦³¦X¨ÖªvÀøªº«e¨Ò¡G2009/03/19¡GSymbyax¡]¦Ê¼~¸Ñ+ª÷µÐÂÄ¡F¤@¿õ·d©w¡^¡]investor.lilly.com/releasedetail.cfm?releaseid=372171 ¡^ 2.¥Ñ¦¹¦^ÀY«ä¦ÒOBI-822¥Ó½ÐBTDªºÄ³ÃD¡AÀ³¸Ó¬O¤´¤í¯ÊÀu¶VªºÁ{§É¼Æ¾Ú¤§¬G¡A¨S¦³Åã¥Ü¥¿±Àø®ÄªºmOS¼Æ¾Ú¥X¨Ó¡A¥ú®³2016¸Ñª¼ªº¼Æ¾Ú¥h¥Ó½Ð¬O¤£°÷ªº¡C SND-13 add-on treatment for adult schizophrenia¡]clinicaltrials.gov/ct2/show/NCT02261519?term=syneuRx&rank=2 ¡^ SND-12 combination therapy for refractory schizophrenia¡]clinicaltrials.gov/ct2/show/NCT03094429?term=syneuRx&rank=1 ¡^ |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/4 ¤W¤È 10:23:25²Ä 569 ½g¦^À³
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¦Ñ¥v¤j¤j ¤Ó·PÁ¤F ²¼ä ºën ºëªö ³Ó¹L¤p§Ì´X¦~ªº¦Û§ÚÅé»{ «Ó³z¤Fªº±M³X ¡§§Ú̪º©w¦ì©M¥ø¹Ï¤ß«D±`©ú½T¡GSyneurRx¬O¤@®a¥H¬ì¾Ç¬°¥»...¨Ã±Mª`¦bÀ°§U±wªÌ¤Î¨ä®aÄݪºCNS·sÃĤ½¥q¡¨ ¬°¤ß®®´£¨Ñ¤F³Ì¦nªºµù¸Ñ ÁÂÁ±z! ¤]ÁÂÁ¤j®a! |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2017/4/3 ¤U¤È 09:56:01²Ä 568 ½g¦^À³
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²q·Q¤jô §Ú¤]¤£ª¾¹D¦p¦ó¬d¸ß±M§Q«OÅ@¡A´N§Ú²z¸Ñ²³æ»¡©ú Sarcosine»Psodium benzoaten°µ¦¨ÃĪ«ªº¸Ü¡A§l¤ô©Ê¡B¦w©w©Ê¡B·»¸Ñ«×¦³¤£¤Ö°ÝÃD¡ASND12¬OFDA°eªº¤j§¡A¤]´N¬O¥i¥H±Nsodium benzoate»Pclozapine¥´¦¨¤@¿õ¡A¦ý¨âÁûÃÄ¥´¦¨¤@Áû¡A¤£·|¬O1+1=2³o»ò²³æ¡A³o¨Ç°ÝÃD¥i¥H±qco-crystal form¥h³B²z¡A§Ú¬Û«H¤½¥q¤w¸g±q³o¤è±§¹¦¨«OÅ@......(¤é²±³ø§i¦³´£¨ì´¹«¬µ²ºc¤@µü)¡C ©µªø±M½æ´Á¬O©t¨àÃÄSND11&12»P«C¤Ö¦~¥ÎÃÄSND11ªºÀu´f§a Sigma-1§Ú¨SŪ¹L¤£´±¶Ã»¡¡An¤£n¦bªÑªF·|¤W½Ð±Ð½²±Ð±Â¡H ¤é«e±Ð±Â±µ¨üªk°ê´CÅé³X°Ý¡A¤º®e¤w©ó¤T¤ë29¤é¥Zµn©óºô¸ô¡A¥Îlinkedin±b¸¹´N¥iµn¤J¡A ¦³¨S¦³¼ö¤ßªºªB¤Í¦³ªÅ½Ķµ¹¤j®a¬Ý©O¡H pharmaboardroom.com/interviews/interview-guochuan-emil-tsai-md-phd-mas-founder-ceo-syneurx-taiwan/ |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/4/2 ¤U¤È 02:55:44²Ä 567 ½g¦^À³
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¦Ñ¥v¤j¤j «ôŪ¤j§@¡A²`²`·P¨Ø ¤p§ÌÁö¾\Ū¦h¦¸¡A¤´«Ý§V¤O ¦]¦³¦p¤Ñ®Ñ¡AÁö§V¤O¬d¸ß¡A¤]µo²{³¡¤À±ý¤F¸Ñ¦ÓµLªk¬dª¾¤§³B ¤ß·Q¥H±z¬ã¨s¤§¼s §ë¤J¤§²`¡AÁÙ¦³¥Î°Ý±o³Ì§Ö ¦]¦¹·Q½Ð±Ð±z ¤ß®®ªº·sÃÄ¡A¦³³¡¥÷±N¥H505(b)(2)¥Ó½Ð¡A¦]¤£¬ONCE¡]New Chemical Entity¡^¡A©Ò¥H±M½æ´Á¦³¤T¦~ ¦ý¾Ú³ø¸ü¡A¤ß®®±N"³z¹Lì®ÆÃÄ¡B¤¤¶¡Åé¡B¾¯«¬¤Î¨Ï¥Î¤èªkµ¥¥|¼h"°µ±M§Q«OÅ@¡A¨Ó©µªø¾P°â±M½æ´Á ¥i§_½Ð±z´N©Ò¤F¸Ñ¡A²n¸Ñ´b¦p¦ó¬d¸ß±M§Q«OÅ@? ¥t¥~±z¹ïANAVEX 2-73ªº¬Ýªk¦p¦ó?©M¤ß®®ªº²Ê²¤¤ñ¸û http://www.epochtimes.com/b5/16/12/16/n8598063.htm http://www.anavex.com/files/Anavex_Presentation_Spring_2016.pdf ¤p§Ì¤í¯Êª¾Ãѵû¦ô ¦³½Ð¦Ñ¥v¤j¤j«ü¾É µMY±z¨SªÅ ¤]¨SÃö«Y ÁÂÁ±z! |
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·|û¡G«i©¹ª½«e10141841 µoªí®É¶¡:2017/3/30 ¤U¤È 09:39:32²Ä 566 ½g¦^À³
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¶W¯Å¤ñ¤@¤ñ~ ¤@ÓBTD ¨ì©³È¦h¤Ö¿ú? Sage ²£«á¼~Æ{ªºBTD, ¤½¥q¥«È25»õ¬üª÷, ²£«á¼~Æ{²¦³º¬O¤p²³¥«³õ, ¦Ü¤Ö¥u¦³¥@¬É¤@¥bªº¤H¤f¦³¥i¯à·|¦³, ÁÙn¦bÂå°|¦Q¤ô60Ó¤p®É ¤ß®®¨âÓBTD, ¥Ø«e¥«È2»õ¬üª÷¤W¤U ¤ñ§¹¼úµP¤ñ¶i«× ¸Ñª¼¥¢±ÑªºÂû¸Àn¸õ, ¥Ø«e¥«È¤j·§100»õ¥x¹ô¤W¤U ¾¶Y´HÂͪº¶Àª÷²Õ¦X, ¥Ø«e¥«È¤j·§500»õ¥x¹ô («z¶ã~~) Well.... ¨â±i¼úµP+ ¥|ÓP2& P3ING.... Thanks for such an irrational market! BTW, ¶Àª÷²Õ¦XÀHÀH«K«K¤@Ótrial ¨S¦³¤T¦~¤¦~¨«¤£¨ìprimary end point, CNS...seems by weeks! ¥u¯à»¡§Úªº«C¬K¦³.... |
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https://drive.google.com/file/d/0B9Vuop5ykN_zanlKSEg4UUg0SWs/view?usp=drivesdk ¤é²± https://drive.google.com/file/d/0B9Vuop5ykN_zV0dpY0RQNVUya00/view?usp=drivesdk ¤¸´I https://drive.google.com/file/d/0B9Vuop5ykN_zSF9uWTNOUm1hdWs/view?usp=drivesdk ´I¨¹ |
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yuki ¤j, «D±`·PÁ§AµL¨pªº¤À¨É! µ¥«Ý¯E¹©¦¨¥\ªº¦P®É! ¤]´Á«Ý¤ß®®¯à¶}©l¹ñÅSÀY¨¤! |
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yuki ¤j, «D±`·PÁ§AµL¨pªº¤À¨É! µ¥«Ý¯E¹©¦¨¥\ªº¦P®É! ¤]´Á«Ý¤ß®®¯à¶}©l¹ñÅSÀY¨¤! |
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¥i¥H¨ì¤½¶}¸ê°T¯¸¬d¸ß¡A¨é°Óªºµ¥µ¥·Q¿ìªk©ñ¶³ºÝ¦Aµ¹±z http://mops.twse.com.tw/nas/STR/657520160321M001.pdf |
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hello yuki ¤j, ¯à§_¤À¨É¤@¤U¤ß®®ªºªk»¡·|³ø§i¤Î¨é°Ó³ø§i, §Ú¤]¤@ª½¦bªø´ÁÆ[¹î¤ß®®, ¤§«e¶R¤F160³Q®M¤F´X±i, ¦]¬°¤F¸Ñ¤£°÷, ©Ò¥H¤@ª½¤£´±¦A¥[½XÅu¥! ÁÂÁÂ! |
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