@Svalli am not going to come back at the utter rubbish you spout in your other replies especially with regards to your very first post, for the sake of the forum
But i will back up my original post that there is no Guarantee that A RPD Voucher will be awarded as you imply
Perhaps you would like to go through the latest news On rppd and the issue of the voucher
.Mate, have a slow read of this and tell me which criteria ATL1102 doesn't meet?FYI Mate https://www.kidsvcancer.org/creatin...se-priority-review-voucher-program-permanent/Pursuant to the 21st Century Cures, the Creating Hope Act pediatric PRV is reauthorized until September 20, 2020.
Moreover, drugs that receive rare pediatric designations by that date will qualify for vouchers as long as they are approved by September 20, 2022. as long as they are approved by September 20, 2022.alsohttps://www.thepharmaletter.com/article/fda-doles-out-two-more-rare-pediatric-designationsSubject to FDA approval of TK216 for the treatment of Ewing sarcoma, Oncternal may be eligible to
receive a priority review voucher if the marketing application submitted for the product satisfies certain additional conditions, including approval no later than September 30, 2022 (unless this statutory sunset provision is modified by Congress). If issued, this voucher may be redeemed to receive priority review for a subsequent marketing application or may be sold or transferred to another sponsor.
I suppose Diamond was a step ahead of you when he said it is not Guaranteed perhaps he is aware if the drug is not passed by
September 22 we may well not Qualify So i will just reiterate once more what our CEO said
“The designation doesn’t guarantee a voucher, you still need to meet the eligibility criteria,” Mr Diamond says. “But having the designation gives you confidence the FDA believes the disease you are treating meets their conditions.”But hey according to you, we shouldn't listen to our CEO should we, we should take notice of some random on hotcopper spouting guarantees after initially trying to scaremonger holders out of their stock with his/her first post then once onboard pumping the stock until exiting probably never to be seen again
like i said been here long enough now to see them come and go
GL to all LT
See how we go
