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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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²Ä3¦W±wªÌ¥ÎÃÄ2¶g«á´N¦³Åå¤HÀø®Ä¥X²{!!!
CytodynªÑ»ùªñ¤é°ªÂI1.54,§C»ù«ù¦³©ñªø½u!!!
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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CytoDyn总µôݺ®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¡¨
·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.....
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?
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.
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
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!?
leronlimab¡]PRO140¡^·|¤£·|½ÄÀ»TMB355´N±N´¦¾å!
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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2019.11.25ª`®g¤@¦¸¡A¤@Ӥ뤺´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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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¡¨
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CCR5¶§©ÊÂಾ©Ê¤T³±©Ê¨ÅÀù³æ§Ü·sÃÄ
CytoDyn¤½¥q Leronlimab»P¥d¹`Áp¥ÎÀòFDA§Ö³t³q¹D
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¬Q(¬ü°ê14¤é)¡AÁ{§É¸ÕÅçCRO¤½¥q¦w¬üºÍ¥Í§Þ(Amarex Clinical)«Å¥¬¡A¬ü°ê¹«~ÃĪ«ºÞ²z§½(FDA)®Ú¾Ú«nÁ{§É«e¬ã¨sµ²ªG¡A§åã·ÇÃĪ«ÃÙ§U°ÓCytoDyn¶}µoªº·s«¬³æ®è§ÜÅéLeronlimab(PRO 140)»P¥d¹`(carboplatin)Áp¦XªvÀøCCR5¶§©ÊÂಾ©Ê¤T³±©Ê¨ÅÀù(mTNBC)±wªÌ§Ö³t³q¹D«ü©w¡C
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CytoDyn¬O¤@®a¶}µo³Ð·sÀøªkªº¥Íª«§Þ³N¤½¥q¡ALeronlimab(PRO 140)¯à¼Ð¹v¦b¤HÃþCCR5¨üÅ骺¤H·½¤Æ³æ®è§ÜÅé¡A¨ã¦³ªvÀø¦hºØ¾AÀ³¯gªº¯à¤O¡ACCR5»P¦hºØ¸~½FÂಾ¦³Ãö¡A¦¹¦¸µ¹¤©Leronlimab(PRO 140)ªvÀøCCR5¶§©ÊÂಾ©Ê¤T³±©Ê¨ÅÀù(mTNBC)±wªÌ§Ö³t³q¹D«ü©w¡ACytoDyn¤]±N¦bªñ´Á¶i¦æ²Ä¤@¦W¦¬®×±wªÌªºªvÀø¡C
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.......This includes our approval last year of the first monoclonal antibody for HIV intended for the 5,000 to 10,000 U.S. patients who have developed resistance to multiple existing therapies...
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...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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