RNS is comforting5 Apr 2022 16:54
Comforting words from The latest RNS,with Richard Hullihen,sounding more confident after speaking to the FDA
This is a buy for me,
Excerpts from latest RNS. 31/3/2022
The NDA filing follows the Company's receipt of a Complete Response Letter ("CRL") from the FDA on 6 October 2021. Following detailed discussion in the Type A meeting with the FDA, these issues have now been addressed by Polarean in the resubmission.
It is currently expected that the FDA review period will take six months. The Company is making full use of this time with regards to commercialisation and launch preparation and will further update the market once material information is received.
Richard Hullihen, CEO of Polarean, said: "We have resubmitted the NDA for our 129Xenon drug-device combination product, following extensive discussions with the FDA regarding the issues that were raised in the CRL. The entire Polarean team has worked diligently to ensure that all the points raised in the CRL were comprehensively addressed".
"We look forward to completing the FDA review and approval processes necessary to bring our unique technology to market addressing the significant unmet need for our non-invasive, quantitative and cost-effective functional lung imaging."