PDCO
Posted: Wed Jul 13, 2016 8:00 am
Fisher,
I think this was already posted, but like re-reading the interview with Dr. Sergei Gryaznov, I find it more stunning the second time. This is, again from last year's EMA PDCO (Pediatric) Minutes for the meeting on July 15-17 dated August 12, 2015
Janssen-Cilag International N.V; Treatment of primary myelofibrosis/ Treatment of primary myelofibrosis
Rapporteur: Sylvie Benchetrit
Summary of committee discussion:
The applicability of the class waiver to the planned therapeutic indication was confirmed. Potential paediatric interest of this medicine suggested by PDCO: myelodysplastic syndromes, acute myeloid leukaemia, neuroblastoma, Wilms tumour, hepatoblastoma, Ewing sarcoma and central nervous system tumors.
Then, in April 2016 the following:
Janssen-Cilag International N.V; Treatment of Myelofibrosis Day 60 opinion
Oncology
Summary of committee discussion:
The PDCO re-discussed the proposed product-specific waiver for imetelstat in the condition “treatment of myelofibrosis” also taking into consideration the additional information provided by the applicant the PDCO recommended granting a waiver for imetelstat for all subsets of the paediatric population (from birth to less than 18 years of age) .
The PDCO emphasises that the granting of a waiver for the condition mentioned above should not prevent the applicant from considering a development in the paediatric population in indications where there is a paediatric need. In principle according to the Paediatric Regulation, incentives for the development for use in the paediatric population are available even if a waiver has been granted in another condition.
Someone is very interested in exploring Imetelstat for Pediatric cancers. Recall Dr. Scarlett saying (paraphrasing) 2016 is shaping up to be an important year for Geron. It seems with so much interest in the drug going on behind the scenes, it wouldn't be unreasonable to think there may any number of catalysts that could occur before year end 2016.
I think this was already posted, but like re-reading the interview with Dr. Sergei Gryaznov, I find it more stunning the second time. This is, again from last year's EMA PDCO (Pediatric) Minutes for the meeting on July 15-17 dated August 12, 2015
Janssen-Cilag International N.V; Treatment of primary myelofibrosis/ Treatment of primary myelofibrosis
Rapporteur: Sylvie Benchetrit
Summary of committee discussion:
The applicability of the class waiver to the planned therapeutic indication was confirmed. Potential paediatric interest of this medicine suggested by PDCO: myelodysplastic syndromes, acute myeloid leukaemia, neuroblastoma, Wilms tumour, hepatoblastoma, Ewing sarcoma and central nervous system tumors.
Then, in April 2016 the following:
Janssen-Cilag International N.V; Treatment of Myelofibrosis Day 60 opinion
Oncology
Summary of committee discussion:
The PDCO re-discussed the proposed product-specific waiver for imetelstat in the condition “treatment of myelofibrosis” also taking into consideration the additional information provided by the applicant the PDCO recommended granting a waiver for imetelstat for all subsets of the paediatric population (from birth to less than 18 years of age) .
The PDCO emphasises that the granting of a waiver for the condition mentioned above should not prevent the applicant from considering a development in the paediatric population in indications where there is a paediatric need. In principle according to the Paediatric Regulation, incentives for the development for use in the paediatric population are available even if a waiver has been granted in another condition.
Someone is very interested in exploring Imetelstat for Pediatric cancers. Recall Dr. Scarlett saying (paraphrasing) 2016 is shaping up to be an important year for Geron. It seems with so much interest in the drug going on behind the scenes, it wouldn't be unreasonable to think there may any number of catalysts that could occur before year end 2016.