The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data. The extended action date is 16 September 2023.
What are the FDA concerned about?
Https://www.edisongroup.com/research/tyking-along-steadily-through-the-clinic/32395/
Great news ... we have now moved from being a pre-clinical pharmaceutical to a clinical one ... That has to add value ... I don't quite understand why some are complaining about the wording of the RNS. Did they expect the BOD to enhance the truth or lie? ... We've had enough sad news on this BB lately so we can at least be happy when the good arrives. LH&K Mafuta
Tissue Regenix (AIM: TRX), the regenerative medical device company, announces that it has signed an exclusive distribution agreement with Australian Allografts for the distribution of the Tissue Regenix OrthoPure® XT product in Australia and New Zealand. This is subject to regulatory approval from the Therapeutic Goods Administration ('TGA').
As Richard mentions this is some more good news and will (pending approval) give us an additional revenue stream. LH&K Mafuta
Https://twitter.com/NuformixPlc/status/1660992520099119104?t=0nR-AI2VMz16Rb9M50lFfw&s=19
Boards are a bit like TV channels. If you don't like what's showing at a particular time you can always change channel or switch off. That having been said there are other forums where you can have a political debate. LH&K Mafuta
Interesting tweet from Dr Parker: https://twitter.com/sparksinsurrey/status/1659282965594009602?t=naQ5qymgF2lmAeCIqbVjHg&s=19
The combined data gives us great confidence in NXP002's potential as an inhaled therapy for IPF treatment and allows the Company to tell a more complete pre-clinical story to potential licensing partners for the first time. We will now look for opportunities to share this important new data with key players in the rare disease and respiratory disease sectors as we explore all opportunities to progress the NXP002 programme."
Https://twitter.com/Sareumplc/status/1656574707838361600?t=BbM05Z836iEytmrtBx_Tng&s=19