JohnM

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On Microblog: Discussion page for Arch Therapeutics (ARTH)
STM, I'm always interested in your posts and completely agree that Norchi is extra careful about inside information. From his years running a biotech fund, he's also very knowledgeable about the issue. The sensitization study takes three months, not a f[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
Glad to, billy. Norchi lined up all the people needed for the sensitivity test, got them enrolled, and started the test last week. The FDA must have asked for a three-month test. Of course, it is open-label, so ARTH can accumulate data as they go. At the e[...]
On Friday File: An "Independence Day Royalties" Guess, plus Real Money Portfolio updates
Use the search function above and you'll get your answer.[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
$ARTH long. In addition to the two-week turnaround to get the 510(k) filed by the end of September, Norchi committed to file the CE Mark application around the same time - he said it is a "second half event." Also, he said "around the end of the year, [...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
Even worse, NASDAQ double-counts each trade. You sell 100 shares to a market maker and they sell those 100 shares to me. NASDAQ reports 200 shares traded, even though only 100 shares moved from one holder to another. So really only $100,000 of ARTH traded [...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
Norchi said he will start the sensitivity study in the next three weeks, but he didn't say he had started it already, so those who were expecting the "already" announcement sold. I guess they think they are clever enough to buy it back before he makes the [...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
Correct. He will have to raise cash soon. I expect him to go to his current investors to either reprice old warrants so they exercise them now or maybe do a convertible bond. But he could have to do a stock sale. That would come after they PR that the sens[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
You are right. As soon as Norchi realized the CE Mark would be delayed, he split the planned FDA filing into two parts, a 510(k) for external use that could be approved relatively quickly, and an IND for internal use that will require another clinical tria[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
No, the CE Mark is a safety approval that is much easier to get - you don't even have to do a clinical trial. (But you have to get approval from each individual country for reimbursement, and good luck getting that without strong clinical results.) An FDA [...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
The trial is 90 days long. I am talking about the length of time the FDA will review the refiled 510(k) application before giving ARTH final approval.[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
Because this was the only issue the FDA had and because they have approved the study design, I expect a positive outcome to lead to approval. One question is whether the FDA will give them a two-month review instead of the usual six months for a new 5120(k[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
At the LD Micro Conference this morning, Norchi said they will start the sensitivity study in June, complete in three months, file for FDA approval before the end of September, and file for the CE Mark in the second half of this year.[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
arch1, do you fell Norchi is unable to oversee a three-month human sensitivity trial, or do you think Norchi is not capable of negotiating a distribution deal? Or do you see some other obstacle keeping AC5 from the market?[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
hipockts, I think you are being much too negative about ARTH management. (I am very OW.) 1. They did explain why they didn't file for a CE mark. Their manufacturer told Norchi when they would file, which Norchi repeated to investors. The manufacturer then[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
finventurer, if ARTH begins the three-month study on skin sensitivity to settle the only remaining outstanding issue for FDA approval, does that count as an "actual action?"[...]
On Microblog: Discussion page for Arch Therapeutics (ARTH)
hipockets, Arch PR'd the results of the clinical trial here: ir.archtherapeutics.com/press-releases/detail/483/arch-therapeutics-reports-ac5-topical-hemostatic-device They then PR'd the peer-reviewed publication of the complete results here: ir.archther[...]
On Biotech Discussion... continued
$Chuck Butler. Just for the record, he was dead wrong.[...]
On Biotech Discussion... continued
$SCYX long - http://scynexis.com/publications/Abstract%2019%20%20IDSOG%20presentation_final_.pdf Slide 10 "A Multicenter, Randomized, Evaluator Blinded, Active-Controlled Study to Evaluate the Safety and Efficacy of Oral SCY-078 vs. Oral Fluconazole in 9[...]
On Biotech Discussion... continued
$CWBR, Cleveland, if it had been me answering, it would be in moderation due to bad language and threats of legal action.[...]
On Biotech Discussion... continued
$CWBR, Are you saying that DR KSS and Cleveland have sold their shares?[...]

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