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Genedrive plc, a leader in point-of-care pharmacogenetic testing, has partnered with a major U.S. physician group to conduct clinical trials for FDA approval of its Genedrive MT-RNR1 ID Kit. This revolutionary test aims to prevent antibiotic-induced hearing loss in newborns, which has significant health and economic benefits. The test is particularly relevant for the U.S. market due to its birth rates, litigation costs from antibiotic side effects, and favorable diagnostic testing environment.
https://www.tipranks.com/news/company-announcements/genedrive-advances-fda-approval-for-hearing-loss-test
The interesting thing for me is that this is not a pharma but physician organisation , this is why we need funding BUT we will have more cudos with the results as it will be seen as a more independant view as it is delivered by the medical proffession and not a pharma . Also with the conditional approval this will help as NICE carries weight all over the world and the De Novo route is also cheaper and quicker once application goes in .This is the start now if we can get a good finance deal in place by which i mean £4-5m then things and possibly the sp will start to improve .
Prion exactly this i serious cash cow ..
Remarkable news. How many small pharma companies get fast track opportunities like this in the US.
In the presentation JC said that the required planned funding was one of the things the FDA partner deal was waiting on before it could be signed off. The news today makes me think fundraising has probably now been agreed, let’s see if a placing is announced in the next few days.
Funding RNS imminent..Tomoz, Friday or before the end of next week is my guess..!
I think the word "partners" was used before. I took this to mean the firms that will actually sell AIHL across the US. Likely to be different firms involved in different regions. But no hurry to name names as they don't even have the data yet to make the actual FDA application. And to get the data they need funding to pay for the trials. Presumably they will now announce a proper fundraising. It would be very odd if they just went for another RF drawdown instead after just releasing this RNS. They'll need at least a couple of million just to get the trials done.
Thank you Comek2
Boxer 100 per cent agree , anyone who makes decisions based upon what they read here , should not be investing especially if they are de rampling ..
We should be all supporting each other with factual posts , and are opinions that make sense ..
Roger this goes out to you , be consistent ...
Todays news was very welcomed by us all , the SP wont be heading down , and some one has posted on here .. as I advised before we will not go under 5p two weeks ago , I can say with full conviction looking at the graphs , and this is not Financial advise , we will now remain above 7 p until further news ...
Tiger16, they can’t the partner wouldn’t want to until they are ready to announce which they eventually will. The reason being commercial confidentiality which is the norm in business to ward off the competition etc…
This will be back in the red and on its a ar se tomorrow!
Oh sorry its on its ar se with an unexciting 8% rise@!
NDA? I doubt it though
Guys I have a question , and am, humble enough to ask it even with the conviction I have this is big news ..
Playing devils advocate ... Why did they not reveal the Big partner ?
A. they cant ?? that would not make sense ..
B, May be the partner is the business partner as well ?
c They cant Obviously say it is a large key player if it isnt .. so why hold back on details ?
I am quite confused about this ?
Can anyone enlighten us , factually ???
What I think we are seeing here on this board is the dysfunction of human beings in real time..
It's an education? The microcosm of the macrocosm? Absolutely fascinating..
Niss...waiting for funding and then going to buy back in..??
Get the elephant out of the room and let’s move on.
Funding needs sorted asap and then the fireworks will begin in July 2024 ☄️💥🔥.
This was a lackluster RNS. Why could they not reveal the name of the partner? I can't see the wisdom behind issuing this now.
Guys this is the biggest news a life science pharma can achieve .. its really that simple .. The market they have just tapped into his the key to the world ..
A few more RNS confirming funding , nice , and USA Partner .. game over this will be no less than £1 plus ... I said this morning , the next couple of days will the the best entry points .. Now its to late this will open up high tomorrow ..
Fre1 you know why this was £2 right? It was because huge sales were expected in a global pandemic
Also there was about 1/3 of the shares as there is now
Well we know how quickly this can move and multiples of the current sp is not out the question given this was £2 a share historically.
GDR are looking increasingly likely to get placing funding from sticky hands, much like EVG did a couple of weeks ago...
Dilution, sure but when the shares go into new fund managers it shouldn't really worry Pi's.
It's the uncertainty surrounding the funding that's holding the price back ...investors holding back why would they buy at 6 p when tomoz maybe they will be able to buy at 2p 3p 4p..??
Clearly excellent news and some disgruntled shorts here have been caught out trying to deramp. A clinical trial agreement is postive news and paves the way to tap into the huge US market as alluded to in the rns. Tie up with other collaborators one great option.
World wide adaption lol.. we are currently in a few wards in Manchester and one in Brighton
I'll send you some share issue history in a couple of minutes eotb1958