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Yeah FDA could drop Monday morning its very close .
MOST I PAID bid has firmed up gla
ONE of a few i will get . if she drifts more will have another top up . I NOTICED they are bidding more
AS i said will start buying under 8
Ah warrens old adage springs to mind.
"The market is a mechanism for the exchange of wealth from the impatient to the patient"
Hi scoredaginsteps it is a difficult one as tensions grow the closer to expected deadlines and it does appear that the necessity for a further raise and expected FDA News are converging somewhat. It does appear that a few of the larger trades are marked as unknown and being published far later than the transaction times which has appeared to me in the past on other companies that I have been invested that the sp is being held up for a reason. I don't know if that is a MM strategy or just us PI's misunderstanding, but two days when sells exceed buys and not much retrace. I can view this as a good thing for the sp or would it benefit a soon to be released raise? I don't know is the answer but a raise before news might not be a bad decision either! After all we were sort of expecting an £8m raise last time through to profitability and it would ensure working capital even if FDA approval has a slight delay The problem with an early raise is that the II's that supported Geni last time when PI's somewhat shunned the offer would probably demand a stronger discount before approval. Of course it would cause a pull back but how large is hard to estimate as we would be in a stronger position with news flows ahead.
I also believe that the FDA will approve our application but on AIM delays play tricks with the sp even if missed by a few weeks. Anyway I am still feeling positive with a strong BOD that have skin in the game. GLA Swissy
AS doing some calculations in my head .GENI SAY cash burn about 750000 a month so since cash raise approx 3 million burned . Geni got 4 million gross wonder what the net was after costs ? ok geni has had income etc i guess if fda approved a cash raise If fda fails which i doubt it .IT would crash the share price , THOUGHTS FROM a few invested here . I THINK with cash burn at 9 million a year we will need cash sooner than later , AS IT takes time to sell and generate income . FINGERS cross april the latest .
Yes, all hinges on the FDA. Without FDA the next raise will disastrous. There are two reasons for that:
1) They are absolutely terrible at timing raises as they have demonstrated recently, had they raised in summer as originally planned the damage would be half to what we have endured.
2) As we have seen since summer, the company can forecasted 50% growth and very clear plan how to achieve that yet the SP kept dropping to new lows every week for more then 6 months. Clearly there is zero trust and no love for this stock without FDA.
Unfortunatelly no one know when the FDA will come, it is complete guessing game. But I also think that the management is very capable and they might even change plans and avoid the next raise if the sale ramp is going well.
Just bought another 40k shares couldnt resist only going one way !
Sells will push it under 8p ,Dont get it why sell at 8p when u could of sold at 9,5p or 20p coming if approved .ONE thing will add 50000 on a drop
A quick recap to evaluate the ‘RISK’ of a further raise assuming a positive FDA result on CIC score kit approval.
I am only laying this down for discussion and opinion within this group so feel free to express opinions:
At IPO Genincode sp was 44p with 38,636,366 new shares representing 40.42 per cent of enlarged share capital with 95816866 shares in total and MCAP of £42.2M
With recent dilution we now have 176.96M shares with a free float of 97.84M shares and Current MCAP of 16.63M.
Assuming we get FDA approval I am assuming for these calculations we see a 50% rise in SP from todays value (Seems reasonable to me) and we see a raise for a further £4m (as was suggested by BOD at last presentation). Allowing for a 10% discount (it was 5% last time) then raise would be at 12.15p equating to approx. 33m new shares issued. This would give enlarged share base of approx. 209,000,000 and a new MCAP of £25.51M. This in my opinion is a very reasonable assumption as Peers at IPO were rated at 50-100M MCAP.
Assuming that a reasonable MCAP at this new advanced stage could be considered £50M then that would place the sp at 23.92p ( again a figure close to those being suggested by many posters on this BB as suitable).
Therefore in my opinion if the FDA approval result is good then I can’t see a huge risk to my investment from current levels with a new raise. In fact personally I am very bullish on this company which allows me to look even more favorably on the assumptions suggested above as I personally could see a 100% increase on good news but everybody must evaluate their own risk and strategy. Of course there will be peaks and troughs on the way as with all shares and the headwind risk to all investors is FDA approval at this point. However the free float will be deemed incredibly small if approval lands and buy in after approval could be at multiples of the current sp.
I would love to know others opinions and assumptions so DYOR and share if you can as it can only aid the research of potential new investors looking in and promote Genincode in general. Looking forward to next week as news could land any time. Cheers Swissy
Glad to have bought in here after doing research and will top up more for the new tax year ISA.
Just watch the sept 2023 half year report and there very honest . They dont fluff through questions like a lot of companies on the stock market , im holding to 2026/27 thats when the real gains are made . they admit this year heavy investment and cash burn of 750000 a month // correct me if im wrong . break even by mid 2025 and profits in 2026 . imo another cash raise will happen but when but this time better as geni should be over 15p so less dilution . I stand by my 50p a share in 2/3 years /PATIENCE REQUIRED . ALL THE best on this exciting journey
Oops! 3 in TEN of cases, not 20. Big fingers.
I'm still looking in here and thinking of investing, but, on balance , I think I'll wait until the FDA announcement (although I realise I may miss out on a potential rise).
Reason is that , as stated by other posters, FDA takes 150 days in 70% of cases, therefore 3 in 20 take longer (and each time there are questions /pause the time frame starts again - it's referenced online.
With the company needing another £4 million (probably in/by June) , this could get a tad precarious.
Although there's still some time to go and quite a bit of leeway at the moment, but think I will hang fire.
Good luck everyone
Https://www.onearabia.me/global/genincode-cardio-incode-score-chd-risk-assessment-011-20083.html
The new FDA goal is to review De Novo submissions within 150 calendar days for 70% of De Novo submissions, but how long does it take now?
If you would like more detailed information related to this video, please visit our blog posting discussing FDA timelines to review De Novo submissions:
➤ https://medicaldeviceacademy.com/revi...
I WAS IN IMM at 40 to 1.56 i sold and next day or so hit 1.90 i was annoyed for selling before results . Well imm failed it look where it is now lucky call that was .
ITS about 50 percent pass rate maybe im thick i thought it was a slam dunk . AS FDA ADVISE YOU THE ROUTE . Geni are smart cookies so i have my trust , Time line can go way over 90 days for approval but most of us know that .
De Novo-winning devices often lack effectiveness data, analysis shows
Published Oct. 13, 2020
By Nick Paul Taylor
Contributor
Jacob Bell
Dive Brief:
A significant minority of devices brought to market via the De Novo pathway lack positive primary endpoint data from a pivotal trial, according to a research letter published in JAMA Internal Medicine.
The paper, which went live Monday, describes an analysis of 63 FDA De Novo authorizations of moderate-risk therapeutic devices between 2011 and 2019. One-fifth of the devices were not evaluated in pivotal studies, and one-third failed to meet at least one primary effectiveness endpoint in those studies.
Only one device was found subject to an FDA-mandated postmarket study. The Yale and University of California, San Francisco researchers who wrote the paper discussed the value of requiring devices to meet pre-specified endpoints and undergo postmarket studies.
content imageAccess now➔
Image attribution tooltipImage attribution tooltipTRENDLINE
Inside the EU medical device regulation
Dive Insight:
A low- to moderate-risk technology authorized via the De Novo pathway establishes a new classification category that can then open a floodgate for comparable devices to enter the market via 510(k) clearance.
The agency is working to finalize a rule on the De Novo process to “make it more transparent and predictable for manufacturers.” Even without it, use of the De Novo pathway has increased in recent years. FDA cleared 65 devices via the pathway from 1997, the year it was established, to 2012. From 2013 to 2019, FDA cleared 187 devices via the pathway. The authorization rate for 2020 is slightly outpacing last year.
It’s notable that De Novo-cleared devices can serve as predicates for products that come to market via the 510(k) route, which has been criticized by the Institute of Medicine and others as having a low bar for clinical evidence and oversight. As such, the regulatory standards for the De Novo pathway have implications for products beyond the 252 that came to market via the De Novo route between 1997 and 2019.
To assess the evidence needed to get De Novo medical devices to market, researchers scrutinized the moderate-risk therapeutic devices cleared via the pathway from 2011 to 2019. The search found 65 devices that met the criteria.
Twelve of the devices came to market without being evaluated in pivotal studies. Of the 60 studies run to assess premarket effectiveness, 17 missed at least one primary efficacy endpoint. The number of medical devices cleared without pivotal data, coupled to the prevalence of failed studies, shows many products came to market without positive results from a late-phase clinical trial.
Postmarket studies give regulators a way to confirm the safety and effectiveness of medical devices that have mixed or limited clinical data without delaying patient access by requiring more premarket work. FDA made limited use of postmarket studi
Iam in verici dx similar company great products niche market but clinicians very slow to try novel products.
My only problem is previous experience with the FDA is ,it tends too drag out indefinetly ie renalytix took years so hopefully we get closure here tout suite
But wont hold my breath.
Great advice Troajan and nice to see time served guidance to new posters as it shows good will with the best intentions. Have a great weekend ; ). Cheers Swissy
Janet
no disrespect meant to you or any other newbies
but buying into comps that have had huge short term gains,is highly risky,ime not saying theyre going to pullback,but you run the risk of being spiked,(for some reason,newbies go for the high flying hot stock of the time,like your saas)
the trend on here is still in a strong uptrend,but i have no idea,how long it will last,obviously,news could be any week now,so the wait isnt long(the aim market,hates delays of any kind)
try and find/pick comps that are on chart trend lows and have just had a fund raise,with plenty of short term news,to drive that sp.
especially,if they have a good income stream,to fend off the dreaded placings(exploration miners and oilies,are the worst for placings/fund raises,for the traders,those sectors)
any way...gl