Blackngold63... Simply, I share your frustration with respect to the stocks current performance. However, I do NOT believe that it will stay here forever..You mentioned several things in your post so, here are my thoughts..
> YOUR Comment "A lot of us that got into the stock years ago believe in the Product.
I think it is cutting edge.
But still - no results or revenue coming up on 2 years since FDA approval.
Why should we believe a deal is imminent now..?"
My Response: I agree that the product is "cutting edge." In fact, the technology is novel, new and different from anything that has ever existed in wound care. The technology is "Multi-modal". The technology is regulated/FDA cleared and CE Mark approved as a MEDICAL DEVICE.. this is important as it does NOT need the body's chemistry or metabolism to achieve the desired reaction of "peptide self assembly".. this unique mechanism of action allows for the product to be extremely safe, effective and different. (Fibrin, Thrombin, etc products do NOT share that luxury as they DO rely on the chemistry and metabolism of the human body). I could write an entire paper on the safety, utility, advantages and benefits of this product but that is not needed for this post since we both agree that the technology is "cutting edge."
> In terms of REVENUE... Did you happen to listen to the HC Wainwright presentation yesterday? Dr. Norchi mentioned that they will show revenue in the 4th quarter of this year.. While I do Not expect earth shattering numbers just yet, it is a step in the right direction.
> Also, it is important to understand why US revenue has NOT started up until now.. YES, they did receive US 510(k) clearance for AC5 back in December of 2018.. After the marketing clearance, Arch began working on harmonizing the US and EU manufacturing supply chains.. this was a critical step. A company can not and should not launch a new novel product into any market without having manufacturing approval and scalability in place. So, even though the product had the Marketing clearance for the product and its indication label from the regulatory authority, the Manufacturing pieces were still being put in place and signed off on with the FDA. A commercial launch should never take place until the manufacturing capabilities have been approved by the proper regulatory authority.. Arch did just that, they harmonized BOTH their US and EU manufacturing suppliers and received approval on this in the first half of 2020. YES, that took much longer than expected but, delays happen when a company is dealing with the FDA/ regulators.No Short cuts. What is most important is that Arch did in fact get everything approved with the proper regulatory authority.
> your Question: "Why should we believe commercial deal(s) are in the works?" Response: The plan has been and continues to be launching with larger commercial partners that are in need of new products. Arch has never intended to "go it alone." So, why do I believe deal(s) are getting close?.. simple, the KOL feedback is coming in on real world patients- and it's really positive. This is a critical step for new novel products.. Big Pharma greatly looks to KOL feedback to get an better picture of the marketing demand for a product. This is common practice. Just because a deal hasn't happened, doesn't mean that it wont. IMO. We are headed in the right direction.
Your Post:
"Their most basic product dumbed down is an external band-aid.
And that is a huge market.
Unfortunately a number of other products similar to that came on the scene while Norchi was dinking around with this and that."
My response: I am a little confused by this statement.. earlier you mentioned the product as being "cutting edge" yet now say that the most basic product is a "dumbed down external band-aid." I am pretty sure a dumbed down external band aid cannot close a 25 year old burn, or a 10+ year chronic diabetic foot ulcer/ pressure ulcer.. I would strongly recommend that you look into the KOL feedback and take a closer look.. these KOLs stated that the current standard of care had NOT worked on these wounds... yet, when they then treated these wound with AC5 Advanced Wound system, they began to heal.
> Yes, The Dermal sciences market is a multi-billion dollar market. We agree that the addressable market is large.
> I disagree that their are "similar products" out there. And if you are thinking of a Japanese company that claims to have a technology similar to AC5.. Again, I would strongly recommend that you look a bit deeper. There are lots of "imitators" out there. IMO. But again, do not take my word for it, do your own research.
There is a reason the former CMO of Covidien, former CSO of Boston Scientific, former President of Pharmaceutical development for MDCO, Former president of SAGES, Director of MNTA and many others are involved HERE with Arch...
> last point: Cash is thin, no doubt about that.The company has always operated with a thin cash balance.. Is it possible that Arch raises more money, sure. That is the nature of R&D biotech companies.. However, I believe that the company is close to commercial deal(s) based on the fact that we know that have the regulatory clearances/ approvals, Manufacturing in US and EU approved by FDA and harmonized, and positive KOL feedback that further supports the product marketability. IMO
Again, do NOT just take my word for it. Do your our research and make your own decisions.
I believe better times are ahead.
: )
