GetSeriousOK
1 week ago
Yesterday was odd. Wonder if news is coming out.
The US clinical trials won't finish until end of year at the EARLIEST, so it probably wouldn't be about that. Q3 Financials, meh, the NMPA submission was Q4 so any payments won't be on the books in Q3....
Possibly a PR About SMI payments? I, for one, don't think SMI has much money, but at least they got the NMPA application submitted.
Here is some interesting reading about the NMPA's proposed changes to their existing Medical Device Regulation (MDR, aka Order 739). The first one doesn't apply to the LuViva Scan but the second one does:
* Under the existing Medical Device Regulation (MDR, also known as Order 739), an imported medical device must be approved in the country of origin before it can be approved in China, unless the product at issue is an innovative device. The draft MDAL proposes to remove this requirement for country-of-origin approval (Article 47). An imported medical device can undergo the regulatory review and approval process in China in parallel to the same in other countries and shorten the time to market in China.
* Marketing authorizations of medical devices, unlike drugs, cannot be transferred between different entities under the Order 739. The draft MDAL explicitly states that marketing authorizations can be assigned and the NMPA will issue specific implementing measures (Article 58). R&D-based medical device companies can sell the right to their products along with the marketing authorizations in the form of an asset sale.
https://www.ropesgray.com/en/insights/viewpoints/102ji2j/chinas-nmpa-requests-public-comments-on-its-first-medical-device-law-three-key
I say ther first one doesn't apply to the LuViva Scan because it's an "innovative device." At least, the Chinese doctors called it "innovative:"
https://www.biospace.com/leading-cervical-cancer-doctors-support-approval-of-luviva-in-china-based-on-preliminary-review-of-clinical-trial-results
According to Dr. Sui, “We are eager to complete the validation of this innovative technology and submit an application to the NMPA, and we are confident that LuViva will represent the next generation of early cervical cancer detection technology, with its advantages of accuracy, ease of use and immediate results.”
Pacjd
2 weeks ago
Unethical Conduct of Management RED FLAG Reposting
Perhaps GTHP shareholders should bring a Law Suit against Faupel and Blumberg.
RED FLAG GTHP DIRECTORS EFFECTIVELY WAIVED CONFLICT OF INTEREST PROVISIONS OF GTHP'S CODE OF ETHICS
THIS SOUNDS LIKE TURNING A BLIND EYE TO UNETHICAL - CONFLICT OF INTEREST BEHAVIOR BY FAUPEL AND BLUMBERG
What is MOST INTERESTING about GETS posting of 8k item is that in referencing the fee splitting agreement is: GTHP (disinterested Directors "effectively waived the conflict-of-interest provisions of the Company’s code of ethics." "On January 15, 2017, each of the disinterested directors on the Company’s Board of Directors, having considered the interests of Dr. Faupel and Mr. Blumberg and having approved the agreement, effectively waived the conflict-of-interest provisions of the Company’s code of ethics." THIS LOOKS LIKE A RED FLAG TO ME
I will again say that Shenghou LLC the original License Agreement Holder was a sham transaction, as Shenghou did not have the expertise to fulfill its obligation under the same, and perhaps it is a self directed dealing of GTHP assets - Splitting GTHP fees to insiders Faupel and Blumberg who are owners in Shenghou., LLC. and perhaps GTHP effectively waived its conflict of interests code to allow Faupel and Blumberg to receive compensation at the expense of the shareholders of GTHP, without having to disclose this as compensation to these two insiders at GTHP. I would call this turning a blind eye.
myjog
2 weeks ago
Today as per PR, it appears that SMI filed for NMPA. In spite of such a (supposedly) slightly good news, if anyone is wondering why stock didn’t go up? It’s because the liar management of this company is not saying a word about whether or not SMI paid them 700K$ when they filed for NMPA in this PR as per their contractual obligations as stated by this company in 1 of their 10-Qs.
The reason stock’s not going up because absolutely no one believes the liar management of this company when they state the following : The filing with NMPA triggers the continuation of the working relationship between the Company and SMI, with milestones and minimum payments to GTI for devices, disposables, services and royalties of more than $125 million over the next six years.
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125 ML$ for next 6 years, are you kidding me? When SMI couldn’t pay them 200K$ then one must be a delusional to believe that SMI will give a 125 ML$ business to GTHP in next 6 years, forget about actual payments.