Replies to post #146538 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Juno therapeutisch reporter third quarter 2017: Rmat designation for investigational drug JCARO17.

[eagle8]

Sentiment, he stated quick look up on Bing.

I guess he meant Bing search machine.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=136536019


GLTU

[Lykiri]

Bliebird bio reports third quarter 2017 financial results: RMAT Designation grandes by FDA for LentiGLobin drug product in SCD.

[RuleofK]

Does this help?

Consumers Capitalize on Advanc-es in Science (posted July 7, 2017), https://blogs.fda.gov/fdavoice/index.php/2017/07/how-fda-plans-to-help-consumers-capitalize-on-advances-in-science/; Humacyte Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Expedited Review Designation for HUMACYL® in Vas-cular Access for Hemodialysis (March 20, 2017), http://www.humacyte.com/press/humacyte-receives-fda-regen-erative-medicine-advanced-thera-py-rmat-expedited-review-designa-tion-humacyl-vascular-access-hemo-dialysis/; Enzyvant Receives FDA Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation for Investi-gational Therapy RVT-802 (April 17, 2017), http://www.prnewswire.com/news-releases/enzyvant-re-ceives-fda-breakthrough-therapy-desig-nation-and-regenerative-medicine-ad-vanced-therapy-designation-for-inves-tigational-therapy-rvt-802-300440401.html?tc=eml_cleartime; jCyte Receives Regenerative Medicine Advanced Ther-apy Designation (May 2, 2017), http://jcyte.com/2017/05/jcyte-receives-re-generative-medicine-advanced-thera-py-designation/; Vericel Receives FDA Regenerative Medicine Advanced Ther-apy (RMAT) Designation for Ixmye-locel-T for the Treatment of Advanced Heart Failure Due to Ischemic Dilated Cardiomyopathy (May 10, 2017), http://investors.vcel.com/releasedetail.cfm?re-leaseid=1025739.
Note 13.

https://www.google.com/url?sa=t&source=web&cd=7&ved=0ahUKEwjs5PaQzebXAhXhzFQKHY_qB9AQFggcMAY&url=http%3A%2F%2Fwww.bipc.com%2Fassets%2FPDFs%2FNews-Events%2FFDA%2520Sharpens%2520its%2520Focus%2520on%2520Regenerative%2520Medicine%2520Regulation%2520-%2520Barbara%2520Binzak%2520Blumenfeld.pdf&usg=AOvVaw111zOOY4vYpDkkEDvtyf1J

Four approvals and 11 meet the criteria. Not as current as Eagle’s, but as of September.

[Lykiri]

VericelCorp . May 10,2017 : Vericel receives FDA RMAT Designation for lymyelocel T for the Treatment of Advanced Heart Failure due to Ischemic Dilated Cardiomyopathy.

[Lykiri]

U.K. July 18 , 2017- Mallincrodt plc today announced that StataGraft regenerative skin tissue is among the first products to be designated RMAT by the U.
S.FDA.
Nov.8 , 2017- Fortress Biotech today announced that the U.S.FDA has granded Cellvation's CEVA101 RMAT Designation for the Treatment of traumatic Brain injury.

Oktober 02, 2017 "Asterias Announces Two Significant Developments for Spinal Cord Injury Program.
"Also, the FDA granted the compagny's request for AST-OPC1 to be designated a RMAT under the 21st Century Cures Act.
So i found 11 granted: Humacyte, Enzyvant, jCyte , Vericel, Kias (Apr. 17, 2017), Bluebird, Juno Therapeutics, Athersys, Mallincrodt, Fortress Bio and Asterias Biotherapeutics.

See also article from nov. 27, 2017: FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies.
"In September, FDA disclosed that it already had 550 active investigational new drug applications (INDs) related to gene therapies, including 76 active INDs related to CAR-T cellular therapies. As of November 9, it has been reported that a total of 11 RMAT designations have been granted out of 31 requests.