Who in the $&^@ is Zach? Are you referring to Brian Markx, the Certified Financial Analyst, who produced the report? You say he (Zach? Brian?) is “doubtfully credible” and “credibility. . .suspect.”
The information on the timelines came from Dr. Chan. If he was overly optimistic or unrealistic about how long it’s going to take to get Cytosorb to market in the U.S., this is not Brian Marckx’ fault. After all, he challenged the time line of the REFRESH 2 –AKI trial in the following:
“The company continues to guide for hitting the 200-patient mark by Q1 2020 – at that point, which will represent 50% of total expected enrollment, an interim analysis will be completed. Assuming no unexpected issues from that analysis and pace of enrollment reaches ~20/month, CTSO anticipates enrollment will complete by the end of 2020. If all goes to plan, CTSO believes they can have data analysis completed and a PMA application submitted to FDA by ~mid-2021. While we think that timeline leaves little-to-no room for unexpected delays and may be somewhat aggressive (although not unrealistic), if this ends up being pushed back by several months or even quarters from what management is proposing here, it would be largely immaterial from a valuation perspective in our opinion (given the relatively meager estimated cash burn rate at that time, particularly in relation to the commercial upside that would result from U.S. regulatory approval).”
You say, “Zach’s. . . always a regurgitation.” (Again, who is “Zach’s”?) Peach, CTSO is not Pfizer and it is not Merck. It’s a tiny little company with one main product. Where is he going to get information except from management? Is that not what other analysts do? Perhaps he could go to work for CTSO. Perhaps he could hire an industrial spy. Marckx has actually written a very thorough summary of where the company is at this time.
You claim, “There is a high probability there will not be adequate efficacy and safety data, especially in the USA for morbidity/mortality data.” High probability, huh? So the FDA asked for 400 patients in REFRESH 2-AKI. You say there is a high probability that the FDA is wrong. Convince me.
You say, “There could be manufacturing issues once approved.” CTSO has been manufacturing Cytosorb since 2011 for the EMEA and the European market. But once it’s approved in the U.S., all of a sudden there’s going to be manufacturing issues. That's not a compelling argument.
Then you say, “There could be lack of sales due to weak data.” That’s a possibility, one of the risks of investing in biotech. None of the rest of us had any idea that could happen. It was brilliant of you to think of it.
Your closing—“All that most FDA and European companies are becoming far more stringent, scrutinizing, aggressive and demanding.” You want to translate that? What words did you leave out? Are “FDA and European companies” a thing? Was there punctuation omitted from “All that most”?
Just remember, Peach, it’s Zack’s, not “Zach’s.”
