The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Yep poor old Pumpky, you are getting a bit transparent here my old mate. The only way this share can be kept down and anyone can have a go at the company now is of the CH is not lifted. End of. But the chance of that Happening is very very slim. Validated by a third party, validated by Prevails experts, told by FDA what we need to do and worked on by top scientists. Come on Pumpky if no RNS in the morning, get back on board.
Yeah I bet he’s devastated with the hand that he was dealt. I suppose that you just think he’s uneducated because of his speech. Another tip, never judge a book by its cover.
“Harry was clever, articulate and very humble,” said the English teacher Denis McElligott.
You are not really casting yourself in a good light here. I suppose you are the stuffed elephant tonight, but really It doesn’t get much lower that asking people what there averages are and trying to put them down on past investments. I’m sure that your average is lower than mine and I would also have a good bet that i could buy and sell you a good few times over. Money isn’t everything my good friend, chill out a bit and stop for god sake pretending to be Bamba Gascoigne.
the share that keeps giving, fight fight fight!! i think micky will win, dog father when some one has a go at you or disagrees with you why every time do you question their intellect. i mean i’m thick as **** but successful. just curious i’m not having a go.
So effectively they were happy with everything apart from one minor thing. they are not going to re evaluate the whole submission again just the part that they have said needs sorting. The FDA have agreed a plan of how they will be happy if followed that they Hemo will get the CH lifted. To be honest if they fail at this stage it will be very frustrating, but i don't think it can, its a 1/50 shot.
Just to add from the previous RNS all looks straight forward.
Hemogenyx Pharmaceuticals plc (LSE: HEMO), which is developing new therapies and treatments for blood diseases, is pleased to announce the successful completion of its Process Qualification ("PQ") run of the end-to-end process for the manufacture of HEMO-CAR-T cells. This PQ run was a part of the Company's plan to address the U.S. Food and Drug Administration ("FDA") concerns that resulted in a Clinical Hold ("CH") of the HEMO-CAR-T Investigational New Drug ("IND") application, as announced previously. The FDA has accepted the Company's plan.
The process was carried out in the Company's current Good Manufacturing Practice compliant clean rooms. It was followed by analytical release tests conducted by the Company required to verify the quality of the manufactured HEMO-CAR-T cells. The HEMO-CAR-T cells are also being tested by a third party to ensure they comply with a set of required quality attributes.
This PQ run is the only manufacturing run required for the submission of a complete response to the CH of the IND application to the FDA for HEMO-CAR-T. It was the key remaining step prior to applying for the lifting of the CH which is needed to obtain consent from the FDA to commence Phase I clinical trials of HEMO-CAR-T. Following the successful completion of all tests across the PQ run, data will be compiled for inclusion in the complete response submission pack.