To me, this is a make it or break it moment for Biotron, why?
Because the DOW and NASDAQ is now rallied to its max with no background to support it. NASDAQ is at all time high and DOW is very close to its all time high. 20 millions of American lost their job. 2 millions infected with COVID19 and 120k lost their lives. A second wave of COVID19 is imminent after the early easing of lockdown and the recent protests. Florida reported 4000 new cases in 3 days compare to 1000 a week before. Other states also reported a surge in new cases. WHO declared that this is the "worst and most dangerous" moment of COVID19 crisis. Im expecting the DOW to fall, bringing ASX with it. BIT needs major news NOW to support its SP before it's too late. Below are the concerns that I posted nearly 3 months ago:
1.The recent quarterly report is a disappointment. Severely lacking of clarity. 3 months since the announcement about SARS-CoV-2 testing, all that we know is BIT “continues to work with groups within Australia and overseas” and the reason why it’s taking long is it is being done in a “careful, scientifically manner”. It sounds like a top secret nuclear weapons’ program, wherein the start and expected end date, and the names of lab/organisation involved are highly classified.
I’ve read lots of articles of pre-clincical and clinical trials from private and public/non-profit organizations all around the world, still, I could not answer why BIT is taking so long and why it could not reveal more details to SH. “Careful, scientifically manner”? Seriously? So all the trials that I’ve been reading so far was conducted in rough way, that’s why they were so fast in publishing the results?
Let’s not mention about overseas trials, simply because there are too many of them. In Australia: University of Queensland published positive pre-clinical data for 2 existing drugs on the 18th of March and immediately moved on to clinical trial. It also announced international partnership for vaccine development on 9th April and 3 weeks later released positive preclinical findings. Monash University’s Ivermectin (data released on April 20) and SPL7013 (April 15) both testing time took around 2-3 weeks. Mesoblast, FDA cleared on April 6th, positive clinical data released on April 24th. Biotron: still purely speculation at this stage.
2. “No news is good news, they must be working on something BIG”. Sorry but I have to disagree, here is why no news is BAD news:
Anyone who is in the biotech industry would know that there is too much competitions and competitions dictate speed. When I write a research proposal I need to give a timeline and defend the proposal in front of a Board. A common question being asked is “When do you expect an initial result?”. A research idea might sound brilliant at one time but not so brilliant 1 year, 1 month or even 1 week later. Those who fund the research will closely monitor the timeline written in the proposal. If developmental milestones are delayed, the research, although very promising, will likely be terminated.
Recently, a SARS-CoV-2 protein interaction map has revealed targets for drugs to work on. 69 compounds (29 FDA-approved drugs, 12 drugs in clinical trials, and 28 preclinical compounds) are being tested. Many are very close to publish clinical data. While waiting for BIT to conduct it in vitro test “in a careful, scientific manner”, we just hope for all other drugs to fail? Sorry but I just cant put my personal gain on top of humanity.
Being FIRST and being FAST is extremely important for media/public attentions and commercial purposes! Do you remember the name of the FIRST man landed on the moon? How about the Second one? Let’s just imagine Gilead’s AGM, CEO’s speech:“Well, our Remdesivir is not that good. So we decided to enter collaboration with Biotron, which is one of the FIRST companies in the world that succeed in CV’s preclinical study”. Everyone stands up clapping. How about a different speech? “We are very pleased to announce our collaboration with Biotron, the 1001st company whom declared positive preclinical trials… Noooo, please don’t leave yet! They said they were slow because they need to do it in a careful and scientific manner”.
3. OK, consider BIT making an announcement next week saying its compound has shown 90-100% effectiveness in vitro. Also consider that, despite of being a late comer, it still manage to get funding from government or organisations to conduct clinical trials. There are still 3 MAJOR ISSUES it needs to solve.
*Ethics Board: Remdesivir got emergency FDA authorisation to treat CV. Dr Fauci also said Remdesivir is the new“standard of care”. And we already know that COVID19 is life-threatening therefore it will be very hard for NEW clinical trials to be approved. Although current ongoing clinical trials might still be able to continue. BIT needs prove in front of the ethics board that the benefit outweighs the risk in using BIT instead of an already approved drugs to treat COVID patients. Same issue with a new HIV’s drug, it takes years and years of ethics work and usually the drug has to be used in combination with existing drugs to reduce the risk.
* Consider that Ethics board said yes. Next step isPatients Enrollmentfor a randomised trial. First thing is to disclose to the patients that they might be given a drug that might not work in clinical setting. Although I find Redemsivir’s data very discouraging, the media has pumped it as a standard of care. How can we recruit patients for our research once they already heard about a proven drug? We cant say that FDA & Dr Fauci are wrong and the other drugs is actually bad inclinical studyand ours is excellent inpre-clinical study.
*The number of patients: The study design and patient’s selection criteria need to be very specific for the data to be clinically significant. Definitely BIT cannot be given to all COVID19 positive cases. I can explain more but I would like to sum it up by saying that the group of patients that can match our selection criteria is quite limitted. As a late comers, BIT also needs to compete with other drugs for patients enrollment. The situation in Australia now is quite well controlled and I really hope that we wont't have any new cases. Sending BIT overseas for clinical study? Again, because of competitions it will be hard, but not impossible. China now already has its own COVID19 treatment protocols, soon other countries will have their own.
Anyway, if BIT fails to deliver in time and the SP falls to 6c, I would consider it a good re-entry point.
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