familyof5
4 horas hace
Liquidity and Capital Resources
At June 30, 2024, the Company had working capital of $1,603,105, as compared to working capital of $1,365,120 at December 31, 2023.
As of June 30, 2024, the Company has $1,724,417 cash on hand.
familyof5
5 horas hace
My guess is they have a private placement lined up to go through after the IDE approval
I'd file that one under something other than the "guess" category. Who wouldn't take them up on a after the fact opportunity such as that. Have they even been sincerely shopping the note around? (Kind of doubt it) Or is that an opportunity that was predestined that priority be given to a certain loyal investors group. Which I'm fine with by the way. Point is Dr. Korenko would have no issue lining up private placement once the IDE approval is complete.
From Korenko's post Friday it sounds like they have just recently sent off a response to at least one of the FDAs questions. With the BBD designation I think we should hear back from FDA in about a week
Update from the CEO regarding the ongoing discussions with the FDA. General updates will be posted on this platform as new information becomes available. Subscribe to our newsletter at https://t.co/FfgSTxpyrZ for important press releases for #RadioGel and #IsoPet $RDGL pic.twitter.com/1t2fJ1hcnS— Vivos Inc. (@VivosIncUSA) August 16, 2024
This update above comes, as will be the case with the FDA IDE resubmission PR imho, well after said fact occurred. Sounds like the FDA and Dr. Korenko aren't as far a part on solution as a certain individual would have liked for us to believe. The open market BUYS sure ramped up shortly after FDA interaction and dialog.I view that as a good sign. Who wouldn't?.....
08/13/2024*************** KORENKO MICHAEL K
Officer Direct Buy 0.1119 50,000
08/07/2024*************** KORENKO MICHAEL K
Officer Direct Buy 0.1176 50,000
08/01/2024*************** KORENKO MICHAEL K
Officer Direct Buy 0.0872 50,000
Matthew 12:38-39
38 Then certain of the scribes and of the Pharisees answered, saying, Master, we would see a sign from thee.
39 But he answered and said unto them, An evil and adulterous generation seeketh after a sign; and there shall no sign be given to it, but the sign of the prophet Jonas:
3 days in a whale.....nah couldn't be.....well.....nah.....never trust your gut but it would make a intriguing story. Everything I say is my own personal hypothesis and should not be interpreted as anything but.....tick tock
kayak_wench
2 días hace
The first question I asked ChatGPT and its answer
1. what is 'the sprint process' as it relates to FDA Breakthrough device program?
The "sprint process" within the FDA's Breakthrough Devices Program refers to a streamlined approach that the FDA uses to facilitate the development and review of breakthrough technologies. Specifically, it is designed to address specific scientific or regulatory issues more efficiently and collaboratively between the FDA and the device sponsor.
The sprint process is an example of how the FDA is working to adapt its regulatory processes to better support innovation while maintaining its commitment to safety and effectiveness.
The next question I asked based on the above answer was
2. So by definition if a device is undergoing the sprint process than an issue or challenge has been identified by the FDA?
Yes, if a device is undergoing the sprint process, it generally means that a specific issue or challenge has been identified that needs to be resolved to move the device's development or review forward. This issue could be identified by either the FDA or the device sponsor, but the sprint process is initiated to address it efficiently.
The sprint process is used to focus on and resolve these particular issues, which might be scientific, technical, or regulatory in nature. The goal is to quickly find a solution or reach an agreement on the path forward, so the overall development of the device can continue without significant delays.
Third question I asked based on above
3. Is the resolution typically positive or can the resolution involve need for additional testing?
ChatGPT said:
The resolution of issues addressed during the sprint process can vary depending on the nature of the problem and the information available. While the goal is to facilitate progress, the outcomes of the sprint process can include a range of possibilities:
Positive Resolution: In many cases, the sprint process results in a positive resolution where the issue is satisfactorily addressed, allowing the development process to move forward. This could involve the FDA agreeing with the sponsor's proposed approach or modifications that meet regulatory requirements.
Need for Additional Testing or Data: The sprint process can also lead to a resolution where the FDA determines that additional testing, data collection, or further study is required before the issue can be fully resolved. This outcome is common when the FDA believes that more evidence is needed to ensure the device's safety and effectiveness.
Modification of the Development Plan: Sometimes, the resolution might involve modifying the development plan for the device, such as changing the study design, adjusting the regulatory pathway, or revising the testing protocols.
Identification of New Issues: During the sprint process, other related issues might be identified that also need to be addressed. This can lead to a more comprehensive approach to resolving multiple challenges.
Overall, while the sprint process aims for a positive resolution that moves the project forward, it can also highlight the need for additional work, including further testing or data collection, to ensure that the device meets the necessary regulatory standards.
familyof5
2 días hace
Crystal ball is RIGHT more than WRONG.....
the crystal ball isn't a slot machine. It's where gut instinct and good peripheral vision draws a most likely probable outcome.....
familyof5 Re: linkvest post# 178267
Friday, August 02, 2024 3:31:34 PM
In the last 5 days Korenko has made two separate 50,000 purchases. Significance of these last 2 stock buys are they come immediately right after FDA interaction. And first time he has ever done so in such a short time span.....8 weeks ago he purchased 50,000 shares. Could there be additional purchases in the coming days and weeks? This is the first time that I know of where he purchased shares on the open market with such frequency. He is one of only a very select few individuals who knows with a certainty what lose ends are left to satisfy the FDA request. And what is required to meet those expectations. Read into it what you will but there is a old biblical cliche that couldn't be any closer to the truth....."Your actions will always follow your beliefs" .....I anticipate we will be hearing more from him any day now in the not so distant future.....
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174857250
familyof5 Re: WALLnut post# 178739
Tuesday, August 13, 2024 10:54:48 PM
THRICE in THREE+FIVE in TWO+SEVEN in TEN
08/13/2024*************** KORENKO MICHAEL K
Officer Direct Buy 0.1119 50,000
08/07/2024*************** KORENKO MICHAEL K
Officer Direct Buy 0.1176 50,000
08/01/2024 KORENKO MICHAEL K
Officer Direct Buy 0.0872 50,000
07/29/2024 KORENKO MICHAEL K
Officer Direct Buy 0.0935 50,000
06/04/2024 KORENKO MICHAEL K
Officer Direct Buy 0.1687 50,000
11/13/2023 KORENKO MICHAEL K
Officer Direct Buy 0.0517 100,000
10/18/2023 KORENKO MICHAEL K
Officer Direct Buy 0.0536 100,000
familyof5 Re: linkvest post# 178267
Friday, August 02, 2024 3:31:34 PM
In the last 5 days Korenko has made two separate 50,000 purchases. Significance of these last 2 stock buys are they come immediately right after FDA interaction. And first time he has ever done so in such a short time span.....8 weeks ago he purchased 50,000 shares. Could there be additional purchases in the coming days and weeks? This is the first time that I know of where he purchased shares on the open market with such frequency. He is one of only a very select few individuals who knows with a certainty what lose ends are left to satisfy the FDA request. And what is required to meet those expectations. Read into it what you will but there is a old biblical cliche that couldn't be any closer to the truth....."Your actions will always follow your beliefs" .....I anticipate we will be hearing more from him any day now in the not so distant future.....
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174915925
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familyof5 Re: Truthsocial post# 178479
Thursday, August 08, 2024 3:50:32 PM
Wouldn't be hard to close green here as crazy at that sounds.....
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174888926
familyof5 Re: familyof5 post# 178482
Thursday, August 08, 2024 4:05:53 PM
WOW! Mind blown! What a close .1144 UP 1.82% Thank you MM
https://ih.advfn.com/stock-market/USOTC/vivos-qb-RDGL/trades
familyof5 Re: Truthsocial post# 178479
Thursday, August 08, 2024 3:50:32 PM
Wouldn't be hard to close green here as crazy at that sounds.....15:50:17 0.1035 10,000
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174889074
familyof5 Re: familyof5 post# 178488
Thursday, August 08, 2024 4:40:58 PM
RDGL TRADING DATA 08/08/24 Last 10 Minutes
16:00:00 0.1144 5,000
15:59:57 0.11275 900
15:59:51 0.1143 5,000
15:59:42 0.111 5,000
15:59:38 0.111 8,900
15:59:36 0.1109 5,000
15:59:19 0.1082 5,000
15:59:05 0.110 400
15:59:05 0.10805 933
15:58:34 0.107165 16,878
15:58:23 0.1036 20,000
15:57:38 0.1036 43,700
15:57:37 0.1036 4,900
15:57:35 0.1036 5,000
15:57:34 0.10355 5,000
15:57:33 0.1036 2,500
15:57:29 0.104 8,900
15:57:27 0.104 50,000
15:57:24 0.1085 5,000
15:56:30 0.110 100
15:55:29 0.1085 8,900
15:55:08 0.10405 350
15:55:08 0.108455 26,500
15:50:55 0.1035 1,976
15:50:54 0.1035 4,124
15:50:54 0.1035 8,900
15:50:43 0.105 5,000
15:50:23 0.105 5,000
15:50:21 0.1035 5,000
15:50:19 0.1035 10,000
15:50:17 0.1035 10,000
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174889328
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familyof5 Re: familyof5 post# 178535
Friday, August 09, 2024 11:41:15 AM
Nah....probably not going to get those cheapies today. Probably will get another green close though so I'll take the trade off. Monday morning would be a good day to open up some FDA dialog. Yeah definitely be a good day to start having that discussion.....
Date********Close
9 Aug 2024 0.1175 0.0031 2.71% 0.115 0.1189 0.101666 859,328
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174893273
Update from the CEO regarding the ongoing discussions with the FDA. General updates will be posted on this platform as new information becomes available. Subscribe to our newsletter at https://t.co/FfgSTxpyrZ for important press releases for #RadioGel and #IsoPet $RDGL pic.twitter.com/1t2fJ1hcnS— Vivos Inc. (@VivosIncUSA) August 16, 2024
The process is progressing rather nicely so it seems. This update comes, as will be the case with the FDA IDE resubmission PR imho, well after said fact occurred. But who knows.....
kayak_wench
2 días hace
from ChatGPT:
If a device's sprint process involves dosimetry, it means that the issue or challenge being addressed relates to the measurement, calculation, or assessment of the dose of radiation absorbed by a person or an object, typically in the context of medical devices that use or measure radiation.
Specific Implications:
Radiation Safety: Dosimetry is critical in ensuring that medical devices that involve radiation (e.g., X-ray machines, radiation therapy devices, or imaging equipment) deliver the correct dose safely. The sprint process might focus on ensuring that the device accurately measures or controls radiation exposure to avoid under- or over-dosing.
Calibration and Validation: The sprint process might address the calibration, validation, or accuracy of the dosimetry function within the device. This could involve reviewing the methods used to calculate doses, verifying that the device delivers consistent and accurate measurements, and ensuring that it meets regulatory standards.
Regulatory Compliance: The sprint process may also focus on ensuring that the dosimetry aspects of the device comply with relevant FDA regulations and guidelines. This could include addressing any discrepancies or uncertainties related to dosimetry data or demonstrating that the device meets specific performance criteria.
Patient Safety: Ensuring proper dosimetry is vital for patient safety, particularly in devices used for radiation therapy, where the precise dose of radiation is critical for effective treatment while minimizing harm to surrounding tissues. The sprint process might aim to resolve any concerns about the accuracy or safety of the dosimetry features.
Development of New Dosimetry Technology: If the device involves innovative dosimetry technology, the sprint process might focus on validating this new approach, ensuring that it provides accurate and reliable measurements, and determining how it compares to existing standards.
In summary, if dosimetry is a focus of the sprint process, it indicates that the FDA and the device sponsor are working to resolve issues related to the measurement or control of radiation doses, with a strong emphasis on accuracy, safety, and regulatory compliance.