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bigjock being one of those that subtley tried to convey in ODX had more strongly indicated July as approval month than they actually did.
10th July
"Omega are also anticipating Self test approval in the EU (by the end of this month) - That in Itself will be a huge market to target."
Omage never used the word anticipating, as I pointed out at the time, the word they used was targeting, which has entirely different connentations, as has subsequently been proved.
StuJune much better well done , See not that hard is it..
Think I’ve made myself clear.
I’m not overly thrilled with my investment. Sinking funds into odx in 2020 looked a sure way to earn a good return, however that enthusiasm has dissipated.
We are still South of a fair valuation, however clearly there are doubts about the government contract being utilized in full - and with each passing month the market becomes more saturated.
"Wisdom Teeth" to be precise......No function, irrelevant and painful!
When I read comments by TWATcher I think of ........"Wisdom"......
So are you invested and are you serious? Or do you frequent this board as a shorter?
The fact that none of the so called serious investors choose to contribute on this thread to confirm that the results RNS couldn't have been clearer in revising the timeline from targeting end of July for approval, to planning to submit by end of July, is very revealing.
"Specifics and precise timelines are rarely "cast in stone" in any kind of statement TWATcher."
You need to point that comment at the guy that started a thread called "1 day and counting", and is therefore expecting an RNS in the morning, or more precisely at the several regulars on here that contributed to some thinking that the 31st of July was a guaranteed date.
The reason the SP didn't tank is simply because the results were positive enough to avoid any heavy sell off. If the results were bad enough, trust me there would have been a sell off and the SP would have fell further. Even a PI will bail out upon the release of a bad set of results rather than taking a heavy hit as the SP slides.
The reality is ODX had already set our expectations earlier in the year that the results were not going to be fantastic and you could argue that the subsequent fall in the SP leading up to the results was a consequence of this. That being the case the SP is now at fair value based on the results.
Now the reason you give why people are holding onto this share is pure speculation. There will be many reasons us PI's are holding and not selling.....even buying and topping up down in this price region. There may not be any possible downside from here if the bottom is now in. I am not saying this is the bottom but holders will have their own various reasons for not bailing down here in the 50's. I for one am holding as I believe the SP can comfortably get back to £1.00 when the orders start flowing which I believe is just a matter of time.
The frustrations of waiting for these orders differs on your holding position and outlook. The long term investors like me who have invested what we can comfortably afford are usually relaxed about everything even when we stray underwater. The ones who buy shares on T10's with money borrowed from a credit card seem to be the ones that act like an inflated balloon being released, dripping in sweat and fixated on looking at the SP every ten seconds! How can you make rational decisions in such a frantic stressful state. That's why most people lose at this game.
Now one thing you did speculate on which I agree with is........"Sooner or later something has to give one way or the other"
Yes, and it will be upwards......the "when" is the unknown ingredient. Patience will be rewarded and once your trading account goes heavily into credit you won't care that it all happened later than you thought it would have.
For those who are interested, relevant FDA EUAs are published here - but can take a week or more post approval to be published: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
"SP hasn't tanked since it's release"
Lets not beat about the bush, the SP hasn't tanked because we are basically left with two groups of investors, the first are way underwater and are looking for at least a small recovery in order to get out with something, the other group that recognise the potential uplift but can ride the possible downside.
ODX is on a knife edge, any positive news on orders outside of the UK will see a spike (I don't even consider the DHSC contract anymore, its a lemon). But any negative news could see the price crumble to pre-covid levels, Lets not delude ourselves the non-covid business doesn't support the current mcap because the fundamentals clearly demonstrate it doesnt.
Also if we look at the non-covid business, how long is it before the new "Owners" at Mologic/Gad determine that producing a CD4 test at non-profit is a better idea than paying Omega a premium, and that market disappears?
We have seen timelines of Xmas, New Year, Early in the year, March,April,May,June, July and now August.
Sooner or later something has to give oneway or the other.
Specifics and precise timelines are rarely "cast in stone" in any kind of statement TWATcher.
Twas a positive RNS and hence why the SP hasn't tanked since it's release.
Everybody that has any grasp whatsoever on this company is waiting for certain product approvals, which will lift this SP dramatically and also orders which will I believe sound the death knell for the shorting brigade.
At least TWATcher is appropriately named. Best filtered that one.
Thanks Tom, I mean Twatcher ;)
Are you invested in Odx?
Why is it that some only remember the bits they want to ? The quote above was from the RNS on the 8th of june.
The progress on the submission process was updated in the full results RNS just 2 weeks ago.
"Whilst we had hoped to start the utilisation study for home-use earlier, we had to expand the scope of the study to meet additional regulatory requirements, however I am pleased to report that the study has now commenced. We plan to submit the data from the study to our European Notified Body by the end of the month and we are working with them to explore how we can fast track approval. Once we receive approval we have high expectations that our distribution partners will be very successful in the market place with one of the first UK-developed and manufactured self-test products to enter the market. "
"plan to submit the data...by the end of the month"
So on the 6th of June it was "targeting approval by the end of July", but in the results it is now "planning to submit data by the end of July."
Whilst some decided that the 6th of June RNS set the end of July as a "cast-in-stone" date, I did mention on more than one occasion that the word used was "targeting". As it transpires, I was correct.
And note the current phrase is "planning to submit", it is again not cast in stone.
If you listened to the presentation you will know its not likely coming end of July so lets get that correct. Mid August is the timeline for me. A couple of weeks wont matter. Could land any moment though. Sit back and wait. Easy money from here.
……although I will defer to BigJock and accept August!
Seeing Omega has never delivered on time, let alone ahead of time, perhaps we had better defer to the chairman and expect approvals "this year"
"Additionally, we have accessed a COVID-19 antigen lateral flow test from the UK company Mologic Ltd which, following a detailed technical transfer, has been regulatory approved for professional use with self-test approval anticipated this year and is now ready for commercialisation under our own VISITECT® brand."
We are already 4 months waiting to to updated on the discussions .....
"The Company remains in discussion with a number of potential commercial partners looking to order the test and to distribute the test on Omega's behalf and the Company will update shareholders in due course."
RNS in the morning then……‘’ Omega announces that it has begun the process of engagement with its European Notified Body seeking CE marking of the VISITECT® COVID-19 Antigen test, a rapid point-of-care diagnostic test for the detection of active COVID-19 infections as a self-test. The Company is agreeing the protocols required for utilisation studies and will update shareholders as this process progresses. The test is already CE marked for professional-use and the Company is targeting approval by the end of July to allow the test to be sold in Europe for home-use as well. As the global market for Antigen testing develops the Company believes self-test approval will be a key product differentiator, as has already been seen in the UK’’
……although I will defer to BigJock and accept August!
Stutz