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What this share needs is a bit of unadulterated, unambiguous, good news. With no ifs, buts, maybes.
As many will appreciate there has been some very good developments of late, Jorc, production, sales of copper, etc.. Yet somehow..none of those managed to meet the above criteria. So, come along AP and Co, and share some of the good stuff. Many thanks. Ps news of sales would count and build a lot of confidence. Just ask the ODX gang!
I think we know enough to merit follow on trial/s, ramping up the cohort sizes ...which are the next step. I am sure that they are well on the way towards planning these as proposed in the recent REDCAP investor teleconferences.
Generally making rather than losing money...which would be a huge milestone. Look around AIM there are hundreds of companies that don't make money (and many never will!)
Unfortunately the forward guidance is not available due to Covid-19 uncertainties, but 2022 was the expected break-even point. The uncertainty will have held back the SP a little, and the trading update will be enlightening.
“The global regenerative medicine market was valued at $5.444Bn in 2016, and is estimated to reach $39.325Bn
by 2023" cited in the 2018 annual report..
Andy - yes can be a quiet board...pros and cons of course but idiot free so I am content enough.
Broadly speaking this is an important time for the company, as we move towards profitability in the 18 months or so.
That's the element I find particularly attractive... a major inflection point and pretty exciting to be involved with.
The SP was hit hard by a significantly discounted placement back in May 2020, but the money was needed to support expansion of production capacity. Although Covid-19 will have impacted on elective procedures, the expansion work over the next 6 months or so, will provide far more capacity going forward (up to $36 million extra sales per year). Demand has not been the issue here in the past (as the products are world class)- it is supply that has held TRX back. Hopefully we now have Phase 1 of the expansion programme online. We hope to find out more later this month in the anticipated company update.
Each US share is equivalent to 2 UK shares so not quite smashing it..~30% lower value in fact.
...but made me look :-)
So...we should hear about phase 1 expansion this month. It was scheduled to complete last month. Would be great to hear if it is up and running. some statements from the Harman report..
'...Phase 1 to add two new clean rooms at a cost of $1.3m and take six months - enough extra capacity to break even.
Phase 2 adds up to 10 clean rooms at a cost of $4.5m-$5.5m and will take ca.12 months
Expansion completion has potential to add up to $36m p.a. to sales.'
Our current market cap less than 40million.
Worth considering those last two sentences in unison.
In my view there will be a backlog of operations from Covid so a good time to be expanding ready to increase supply, when times are better post vaccines..(fingers crossed)
a good hold here IMO while we await news later this month
I'm just taking on the 'no adverse events' message in the RNS. Now, let's consider this more closely. While we don't know the definition of adverse events, it is likely to include suspected drug reactions, deaths, and potentially worsened state, e.g. requiring ventilation..(also an outcome of the Sng trial). Anyhow, hopefully there is a broad adverse event definition in use and we are looking at a treatment that has indications of efficacy even at this early stage. Truly exciting month.
One point of disappointment is that I expected a recruitment of 60, and we are some way off of that which isn't helpful in the understanding of dose etc and the planning of the follow on trial/s. Can't wait for more news on the results and forward plans.
The observations made during the Clinical study did not show any adverse events.
This is the big bit for me. Of this cohort you would have expected some deaths in the group.
Back at start of December I cautioned that we may not hear from bank straight away as meetings are rarely an end result in own right.. i.e letter to follow. This always made sense to me.. , and then you are in to time frames out of Vast control.
Obviously we expected to have heard because that was what we were led to believe, but that's a different matter.
We shall hear re finance soon enough. If all is well, huge upside from here. Even if doesn't come off we have a decent amount of cash to settle debts and move forwards.
That's my positive spin for the new year. Happy new year one and all.
Just one recommendation from me. TRX. They make regenerative medical products. Huge international market, and board are quietly delivering on all aspects while 4 iis have bought in heavily in past 6 months . Good message board also... Hardman report.. Link below.. would be first port of call. Plus posts of Chester on the messageboard.. Nb his posts kept me in ggp earlier this year. Sales Update due
January.https://www.hardmanandco.com/research/corporate-research/funded-through-to-profitability/
Usual caveats.
Meanwhile.. Cmon AP.. How about some good news for us tomorrow
Antharry.. Hope you are here in six months and hope I am too...As that status would mean a major positive transformation has taken place and we have ourselves a debt free profitable miner with fantastic prospects, having made huge strides in the past 18 months.
The shame of it all is that this should have been the expectation. Now I'm in the infamous hope camp lol. Should be an interesting next few weeks.
Further to my post l, the EUA link from Sample, includes the relevant sentences below vis a vis EUA minimum data.
'An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed before the planned end of the trial once the data have met the pre-specified success criteria for the study’s primary efficacy endpoint.'
The board have said that moving to P3 would be rapid and if positive they may use some of the recent fund raise to prioritise and expedite. It would be good to get details of a plan ASAP in January. I would like to think that government support would be available. This was asked in th recent investor chat and I believe they said they would look into the possibilities. I find it surprising that the sng treatment is not available yet given the desperate need for treatments. What we can guarantee however, is that positive Brazil results will prompt a flurry of activity and interest, and rightly so. Fingers crossed
The next step will have to be a phase 3 trial which the board have suggested would be multi site. UK and USA probably to reflect the subsequent approvals they would seek... E. G. EUA. So yes a larger cohort. They only had 60 cases I believe in the Santos trial, so it's some way from EUA yet. Nb. The trial has relevance not only to Covid but to other conditions resulting in respiratory attack.