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Posted On: 04/13/2022 6:15:24 PM
Post# of 148902
Keep your aviator glasses on…because a pig might just be flying by you pretty soon.
Let’s see Craig… we had the list from the RTF letter and the major issues were to be tackled by Dr Rae and he is a pretty bright guy… PHD and all. Dr. Rae spearheading the overseeing of this re-file effort is probably our saving grace. He hired two CRO’s to do the RO and dosage difference’s that Amarex never attempted to make good happen when told by the FDA that they were not correct in our rolling submission first time around by the FDA.
Does any of this sound familiar? There were small issues about injection needles and the prepackaging or something like this but the list was not so terrible that Dr. Rae couldn’t resolve the all issues in house and the items he didn’t want to tackle he hired it out. Last I heard the RO and the Dosage issues were now being or have been totally resolved. I am thinking resolved by our two new CRO’s Dr. Rae hired. The only thing now was for Dr. Recknor to sign off on a completion on the data from the audit to be sure we have all the pertinent information from the last attempt and the safety efficacy aggregate being the new discovery that Amarex never tracked all our trials in a aggregate format.. This was supposed to take another 8-12 weeks to gather that information from the audit and the master file so we could file our BLA and get back in the good graces proving Leronlimab has no safety issues.
So to your next statement will we have a BLA filed this year? I believe so… maybe it’s 8-12 weeks away or maybe it’s a little sooner. Depends on the safety issue being approved by the FDA. So say we file it and we do have to adhere to time lines after a submission. 60 day acceptance then a PDUFA date assigned. I believe our fast track designation still applies so as soon as 6 months after our BLA acceptance we could have a possible approval.
Let me do the math for you… 12weeks = 3 months and 60 days= 2 months then PDUFA date= 6 months. Looks like 11 months from now (or a month sooner) if everything right now is actually checked off the list of FDA’s RTF letter. I believe it is but we don’t have a confirmation of that other than what Dr. Recknor said in the last CC and you can go listen to it again to be sure what he said because he did comment on when.
So we should file this year and duck low when it happens because flying pigs will lay you flat when they hit you.
Let’s see Craig… we had the list from the RTF letter and the major issues were to be tackled by Dr Rae and he is a pretty bright guy… PHD and all. Dr. Rae spearheading the overseeing of this re-file effort is probably our saving grace. He hired two CRO’s to do the RO and dosage difference’s that Amarex never attempted to make good happen when told by the FDA that they were not correct in our rolling submission first time around by the FDA.
Does any of this sound familiar? There were small issues about injection needles and the prepackaging or something like this but the list was not so terrible that Dr. Rae couldn’t resolve the all issues in house and the items he didn’t want to tackle he hired it out. Last I heard the RO and the Dosage issues were now being or have been totally resolved. I am thinking resolved by our two new CRO’s Dr. Rae hired. The only thing now was for Dr. Recknor to sign off on a completion on the data from the audit to be sure we have all the pertinent information from the last attempt and the safety efficacy aggregate being the new discovery that Amarex never tracked all our trials in a aggregate format.. This was supposed to take another 8-12 weeks to gather that information from the audit and the master file so we could file our BLA and get back in the good graces proving Leronlimab has no safety issues.
So to your next statement will we have a BLA filed this year? I believe so… maybe it’s 8-12 weeks away or maybe it’s a little sooner. Depends on the safety issue being approved by the FDA. So say we file it and we do have to adhere to time lines after a submission. 60 day acceptance then a PDUFA date assigned. I believe our fast track designation still applies so as soon as 6 months after our BLA acceptance we could have a possible approval.
Let me do the math for you… 12weeks = 3 months and 60 days= 2 months then PDUFA date= 6 months. Looks like 11 months from now (or a month sooner) if everything right now is actually checked off the list of FDA’s RTF letter. I believe it is but we don’t have a confirmation of that other than what Dr. Recknor said in the last CC and you can go listen to it again to be sure what he said because he did comment on when.
So we should file this year and duck low when it happens because flying pigs will lay you flat when they hit you.
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