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·|­û¡GROGER588910148151  µoªí®É¶¡:2020/3/31 ¤W¤È 05:26:58²Ä 915 ½g¦^À³
cytodyne¬Q¤é¦A³Ð·s°ª3.5

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Leronlimab(PRO140)ªv¦Ê¯f,ªÍª¢­«¯g¤]¦³®Ä???

¬Q¤éöt46%+.

¦³¨S¥i¯à¬O¤U¤@¤äHumira???

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·|­û¡GROGER588910148151  µoªí®É¶¡:2020/1/31 ¤U¤È 11:22:06²Ä 913 ½g¦^À³
CytoDyn Announces Stunning Results from Clinical Trials Evaluating mTNBC and MBC with Leronlimab and will Request an Emergency Type C Meeting with FDA to Enroll 50 Awaiting Patients with a Serious Solid Tumor Cancer Condition

Third patient data supports leronlimab (PRO 140) as a potential treatment option for metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC). Patient CTC dropped to zero after 2 weeks of leronlimab treatment, same as the first patient on leronlimab

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·|­û¡GROGER588910148151  µoªí®É¶¡:2020/1/17 ¤W¤È 06:16:42²Ä 912 ½g¦^À³
Superfast!!!

³o»ò¼ö·R·sÃĪѡA¬ü°ê¤@¤j°ïÄvª§¤O§ó±j¦a¼ç¤OªÑÅý±z¿ï¡A»¡¤¤¤å´N¯à¶}¤á¤U³æ¬üªÑ¡A¦ó¥²µe¦a¦Û­­!

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Leronlimab is in an extremely favorable situation, tested for over 830 people and the FDA knows it very well, CYDY is in the BLA submission phase for Leronlimab for HIV-1, so this is not an unknown drug with only a few treated cancers patients. And that¡¦s why Leronlimab for the treatment of cancers immediately receives Phase II within a record time after the application( without the need for Phase I), now BTD and I believe the approval of Leronlimab for cancers can come in record time, much sooner than many expect.

If a BTD is granted the possible outcomes are (a) conditional or full approval, (b) expedited development, (c) rolling submission, or (d) review shortened.

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·|­û¡GROGER588910148151 µoªí®É¶¡:2019/12/30 ¤U¤È 09:32:07²Ä 902 ½g¦^À³

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CytoDyn总µô­Ý­º®u执¦æ©xNader Pourhassan³Õ¤hªí¥Ü¡G§Ú们¦³¨¬û{ªº结ªG¤ä«ù¦b2020¦~1¤ë¥Ó请¬ð¯}©Ê药ª«资®æ¡]BTD¡^¡C¡¨

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·|­û¡GROGER588910148151 µoªí®É¶¡:2019/11/23 ¤W¤È 07:47:47²Ä 875 ½g¦^À³

·³¥½¦~²×±N¦Ü,¦^ÀY¤@±æ¤dª÷Ãø¶R¦­ª¾¹D,³sPRO140¤]³QGS-6207±½¨ì!!!

2019.11.12: 6个¤ë¤@¦¸¥Ö¤Uª`®gHIV长®Ä疗ªk¡I¦N§Q¼w³Ì·s数Õu¤ä«ù·s«¬HIV-1¦ç壳§í¨î剂GS-6207开发¡I

news.bioon.com/article/6746445.html (¥Î©óªìªv»P¦h­«§ÜÃĩʱwªÌ)]

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1¤ë14¤é JPM°·±d¤j会¤W¡AGilead Sciences总µôO¡¦Day°µ报¹D讲¤F¤L点.... HIV¦ç壳§í¨î剂GS-6207¦³两Ïú剂«¬¡G¨C©P¤@¦¸ªº¨î剂¥i¥H¤fªA¡Fª`®g¨î剂¥i¥H¨î¦¨¨C¥b¦~ª`®g¤@¦¸ªº药ª«¡F¦P时还¥i¥HPrEP¡A¦]¦¹¦³³QFDA±Â¤©Breakthroughªº¥i¯à.....

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To hcs318

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www.logisticnet.com.tw/newsCaseRunDetail.asp?id=394

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hivplusmag³o½gDear Researchers: Fewer Side Effects Please·F¹ÀÂI¦WTrogarzo?

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TMB355¬°¦ó¤£¦n½æ?°Æ§@¥Î®£©È¤~¬O¥D¦]!!!

Dear Researchers: Fewer Side Effects Please

www.hivplusmag.com/treatment/2019/7/22/dear-researchers-fewer-side-effects-please

.....Side effects, both bothersome and serious, can be temporary or have long-lasting consequences. These include diarrhea, lipodystrophy, fatigue, bone pain and/or disease, nausea, and depression. Symtuza, Delstrigo, and Trogarzo (all of which are among the drugs approved in 2018) and some of their components are also linked to complications such as immune reconstitution inflammatory syndrome, and liver and kidney disease. Some of these conditions are related to a higher risk of cardiovascular disease.

Despite FDA approval, the extent of the effects of Trogarzo are largely unknown due to the speed of its approval. The drug was approved for those with limited treatment options based on a 24-week, single-arm (not compared to other drugs) study of 40 patients. Most HIV drugs are studied in thousands of individuals and compared to numerous other HIV drugs before receiving FDA approval. The process used to approve Trogarzo, called fast track designation, was created early in the U.S. HIV pandemic to make drugs available quickly for those in desperate need. Although very necessary for some individuals, fast track designation severely limits our knowledge of the effects of a drug.

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·|­û¡GROGER588910148151  µoªí®É¶¡:2020/1/7 ¤W¤È 06:25:53²Ä 907 ½g¦^À³
PRO140(CCR5)«ç»ò¥i¯à¨S¦³°Æ§@¥Î???

CYDY FINISHED a phase 3 trial with almost no side effects.

4¤äÃĪ«°Æ§@¥Î:Fuzeon(13¶µ) /Selzentry(CCR5,7¶µ) /Trogarzo(5¶µ) / PRO140 (0¶µ)

emerginggrowth.com/bio-path-nasdaq-bpth-cytodyn-otcqb-cydy-fact-checking-short-sided-analysis/

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content.equisolve.net/cytodyn/media/9bb625fefc4872db42ac65d15afea2ae.pdf

No serious side effects and no drug related serious adverse events (SAEs) in >740 patients in 8 clinical trials

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·|­û¡GROGER588910148151  µoªí®É¶¡:2020/1/5 ¤W¤È 09:05:03²Ä 906 ½g¦^À³
www.cytodyn.com/newsroom/press-releases/detail/324/cytodyn-and-samsung-biologics-enter-into-agreement-to

Estimated revenue potential of the new leronlimab supply is based upon $120,000 per patient, per year ¡V BLA submission is in process with 1/3 already submitted to FDA

VANCOUVER, Washington, April 02, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (¡§CytoDyn¡¨ or the ¡§Company¡¨) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the execution of a comprehensive strategic agreement with Samsung BioLogics Co., Ltd. for the clinical and commercial manufacturing of leronlimab (PRO 140). The quantity of new leronlimab to be produced under the agreement is anticipated to be sufficient to support potential revenues for CytoDyn of approximately $1 billion based upon $120,000 per patient, per year.....

It is believed the financial obligation to Samsung will be satisfied predominantly with sales from existing inventory of commercial grade leronlimab and non-dilutive financing.

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¤§«e»¡ÃĶO7.5¸U,²{¦bÃĶO12¸U, 10»õ¬ü¤¸(8300¦W±wªÌ)­n½æ´X¦~,¯ä§¾¤T¬P¦¬¤J¬Ý±z®aleronlimab0 ,¬Ý¨Ó¤]¬O§j¤û¤j¤ý¤@­Ó!?

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2020¦~将¦b¬ü欧获±o监ºÞ§å­ãªº10个§ÜÊ^药ª« news.yaozh.com/archive/28152.html

leronlimab¡]PRO140¡^·|¤£·|½ÄÀ»TMB355´N±N´¦¾å!

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·|­û¡GROGER588910148151  µoªí®É¶¡:2020/1/1 ¤W¤È 09:30:52²Ä 904 ½g¦^À³
GILDILD§Y±N­±Á{leronlimab(PRO140)½ÄÀ»!?

565¦W±wªÌPRO140[³æÃÄ]ªvÀøªñ¤@¦~...

CytoDyn In the Running as Trump¡¦s PrEP Replacement Plan

Gilead Maintains Dominance - But for How Long?

Samsung Biologics ready to provide them with up to $1.0 billion of inventory

¦³¶R¬üªÑªÌ­nÃöª`Cytodyn¤@¤U!

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seekingalpha.com/article/4312978-politics-of-hiv-political-football-fumbled

It¡¦s important to note that 565 leronlimab monotherapy patients have literally thrown away HAART, the standard of care, for close to a year. Five special patients have even been off the side effect heavy HAART 5 years, demonstrating leronlimab¡¦s considerable resilience to patients¡¦ developing drug resistance, attributable to the fact that leronlimab mostly prevents the virus from ever replicating. Leronlimab may prove to be a superior option over HAART for many patients.

The HAART standard of care, which leronlimab theoretically has the potential to disrupt, represents a >$15 billion franchise for GILD, but the leronlimab monotherapy patients are living ART-free and have complete control of their HIV. Contrast leronlimab¡¦s viral rebound data to GILD¡¦s GS-9620 animal study, which saw viral loads rebound in 112 days (less than 4 months). Patients in CytoDyn¡¦s monotherapy trial are essentially represented by the orange line in the Functional Cure graphic (a few graphics) above, and many patients could remain functionally cured without side effects for years to come, since CytoDyn doesn¡¦t have any strong evidence of viral rebounds yet.

....

The CytoDyn story, once again, could be too good to be true. However, the company is weeks away from a planned BLA submission that will result in a planned drug approval by June 2020, based on its rolling BLA and fast track status. In September, CytoDyn signed a non-binding licensing deal for $90 million from a major distributor. Once the drug is approved, the company has Samsung Biologics ready to provide them with up to $1.0 billion of inventory, based on anticipated drug prices, to meet the expected demand. CytoDyn also signed with distribution partners ready to market the drug.

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这¨Ò±wªÌ¦b11¤ë25¤é±µ¨ü¤F­º¦¸leronlimab输ª`¡A剂¶q为700mg¡A¨C©P¤@¦¸¡C¦b­º¦¸输ª`leronlimab¤§¦Zªº两个时间点¡A对这¨Ò±wªÌ转²¾©Ê¯f¨_进¦æªº两¦¸¦Z续扫´y结ªG§¡显¥Ü肿½F缩¤p¡B脑¤ô肿ú£¤Ö¡A¦Ó¥B©ú显¦a¡A¤L个转²¾肿½F®ø¥¢¤F¡C

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2019.11.25ª`®g¤@¦¸¡A¤@­Ó¤ë¤º´NÅã¥Ü¥XÅå¤H®ÄªG---§Ú们¦³¨¬û{ªº结ªG¤ä«ù¦b2020¦~1¤ë¥Ó请¬ð¯}©Ê药ª«资®æ¡]BTD

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¥Ø«eÁöµM¥u¦³¦U¤@®×¨Ò,¦ü¥GªvÀø¤T³±©Ê¨ÅÀù»PÂಾ©Ê¨ÅÀù¤w¥X²{¯«ÃÄ!?

¹v¦VCCR5ªv疗¨Å¸¢Àù¡Ileronlimab(PRO-140)¦b¤T阴©Ê¨Å¸¢Àù(TNBC)©M转²¾©Ê¨Å¸¢Àù(MBC)®i现üL劲ªv疗ýͤO¡I

2019¦~12¤ë30¤é讯 /¥Íª«¨¦BIOON/ --CytoDyn¬O¤@®a专ª`¤_开发·s«¬¤H·½¤ÆCCR5«ú§Ü剂leronlimab¡]PRO140¡^¥Î¤_¦hÏúªv疗Óì应¯gªº¦Z´Á临§É阶¬q¥Íª«§Þ术¤½¥q¡Cªñ¤é¡A该¤½¥q«Å¥¬¡Aleronlimabªv疗转²¾©Ê¤T阴©Ê¨Å¸¢Àù¡]mTNBC¡^ªºIb/II´Á试验©Mªv疗转²¾©Ê¨Å¸¢Àù¡]MBC¡^ªº试验继续显¥Ü¥X«D±`¦³ýͤOªº临§É应µª¡C

来¦Û­º¨ÒmTNBC±wªÌªº进¤@¨B数Õu显¥Ü¡A¦b¨Ï¥Îleronlimabªv疗11©P¦Z¡A¥~©P¦å¤¤没¦³¥i检测¨ìªº´`环肿½F细­M¡]CTC¡^©Î转²¾©Ê肿½F细­M¡A¦bÀù¯g¬Û关细­M¤WCCR5ªºªí达¤]进¤@¨B­°§C¡C¦b«æ诊IND¤è®×¤¤¡A¤@¨ÒMBC±wªÌ±µ¨üleronlimabªv疗¤T©P¦Z¡A³q过MRI显¥Ü肿½F缩¤p¡C

CytoDyn¦X§@¥ë¦ñ¡B单细­M诊断¤½¥qIncellDx­º®u执¦æ©x¥¬鲁´µ•©¬¯S´Ë¡]Bruce Pattersonªí¥Ü¡G¡§¦b²Ä¤@¦ì±wªÌ¨­¤W¡A§Ú们«Ü°ª兴¬Ý¨ì¡Aleronlimabªv疗11©P¦Z¡A这¨Ç额¥~ªº数Õu进¤@¨B´£¨Ñ¤F疗®Äªºªì¨B证Õu¡A«ù续检测¤£¨ìªºCTC¤ô¥­©MÀù¬Û关¥¨¾½细­Mý©细­M¡]CAML¡^ªºú£¤Ö´N证©ú¤F这¤@点¡C¨ì¥Ø«e为¤î¡A这¨Ç数ÕuÉO¥ý«e评¦ôleronlimab§@为长®Ä疗ªkªv疗HIV·P¬VªÌªº¬ã¨s¤@­P¡A¦bmTNBC试验¤¤没¦³发¥Í严­«ªº¤£¨}¤Ï应¡C¡¨

²Ä¤G¨Ò±wªÌ¬O¤@个4´ÁMBC±wªÌ¡AÀù¯g¤w转²¾¨ì¨x¡BªÍ©M脑¡C这¨Ò±wªÌ¬O³q过«æ诊IND¤è®×¤J组¡C这¨Ò±wªÌ¤w±µ¨üHerceptin¡]»®赛¥Å¡A¦±§´¯]单§Ü¡AHER2¹v¦V单§Ü¡^©MPerjita¡]©¬§´¯]单§Ü¡AHER2¹v¦V单§Ü¡^ªv疗¶W过1.5¦~¡C»®赛¥Å¤wª¾¦bªv疗约12个¤ë¦Z¥¢®Ä¡A¦ÓPerjita¤wª¾¦bªv疗¤j约1.5¦~¦Z¥¢®Ä¡C这¨Ò±wªÌ¦b11¤ë25¤é±µ¨ü¤F­º¦¸leronlimab输ª`¡A剂¶q为700mg¡A¨C©P¤@¦¸¡C¦b­º¦¸输ª`leronlimab¤§¦Zªº两个时间点¡A对这¨Ò±wªÌ转²¾©Ê¯f¨_进¦æªº两¦¸¦Z续扫´y结ªG§¡显¥Ü肿½F缩¤p¡B脑¤ô肿ú£¤Ö¡A¦Ó¥B©ú显¦a¡A¤L个转²¾肿½F®ø¥¢¤F¡C

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finesand.wordpress.com/2019/11/19/cytodyn-cydy-company-update-log/

...Finally corrected PRO 140¡¦s annual marketing price to $75,000 per patient, still below competitive products like Trogarzo w/ $118,000. Cheaper than most if not all other efficient antiretroviral drugs and for sure all cancer drugs.

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.... from the first patient in a Phase 1b/2 clinical trial with metastatic triple-negative breast cancer (¡§mTNBC¡¨). Circulating tumor cells (¡§CTC¡¨) in the patient¡¦s blood decreased significantly after leronlimab therapy at both two-week and five-week time points. Furthermore, ....

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¡§These results show suppression rates with PRO 140 that are very impressive,¡¨ said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. ¡§A small molecule CCR5 antagonist approved for a multidrug class resistance population has shown a viral suppression rate of 48% after 48 weeks, and the latest antibody therapeutic approved for a multidrug class resistance population achieved a 43% viral suppression rate after 24 weeks. ]

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B.PRO140§ð«e½u¥ÎÃĪº»ù®æ·|§ó«K©y¦ý¨S»¡©ú½T¼Æ¦r!(ÁÙ¦³PRO-140¤]­n¥Ó½ÐÀù¯gÁ{§É¹êÅç)Cheaper than most if not all other efficient antiretroviral drugs and for sure all cancer drugs.

•2019-01-14 CYDY has published their January Presentation •Finally corrected PRO 140¡¦s annual marketing price to $75,000 per patient, still below competitive products like Trogarzo w/ $118,000. Cheaper than most if not all other efficient antiretroviral drugs and for sure all cancer drugs.

•$480M initial combo revenue expected in 2020: $3.327/sh @ 610M max-dilution, P/E 15 and 30% discount, eff P/E 10.5 @ 5.25% market-penetration

•Our preliminary update of our model based on new sales price and latest HIV-1 metrics

•Published three interview updates •2019-01-14 Potential Breakthroughs, CYDY is Working Towards in HIV and Cancer Treatment ¡V audio copy on youtube •$180M raised, only 10-15% more required for BLA submission

•¡§mechanism working for any cancer that has CCR5, will be effective¡¨

•¡§50% of the breast cancer that metastasized have CCR5¡¨

•¡§The (cancer) market for such product could be in trillions, not billions, but trillions¡¨, said Pourhassan

•¡§non-dilutive fundraising is around the corner people in Europe are asking for Pro 140 .. to use it in the trial .. they want to collaborate with us they want to use Pro 140 as a sustaining mechanism¡K they are talking about licensing for the HIV and cancer with smaller and bigger pharma¡¨, said Pourhassan

•2019-01-11 CytoDyn aims to be ¡¥paradigm-shifting¡¦ in cancer management with its platform drug leronlimab

•2019-01-07 Monoclonal antibody HIV treatment w potential FDA approval in 2019

•Ongoing raise to complete financing of full BLA filing, where BLA stage-1 is done

•2019-01-03 CYDY has progressed extremely well over the last three month. Updated evaluation model. Only issue holding back company is still the nagging about appropriate financing to achieve HIV-1 Combo approval. See completed events in list below. •Fully diluted OS is around 466M, AS has been increased to 600M •27M shares for Pestell/Prostagene

•40M shares @ $0.50 + 40M Warrants for $20M raises since 9/25 assumed

•TNBC IND filed and approved, phase 1b/2 trial to be started January ¡¦19, initial readout 1Q19

•Discontinued CD03 Monotherapy 700mg w/ ~92% responder rate, 24/26 for 12 weeks, VL rebound happened due to ordinary immune reactions (flu shot, cold).

•Pestell/Prostagen acquisition has been closed

•Prostate Cancer Prognostic Test development to be completed and seeking FDA approval

•CYDY holding CCR5 antagonist cancer treatment patents (p26), unavoidable for BP to deal with.

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