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Looking strong this morning.
Agreed!
Guess it is your typical sell the news.
It will be very interesting to see how todays presentation affects the share price this week.
By James La Rossa| November 16th, 2017
Nice volume and share price increase this week.
I still have a lot of respect for Dr. Norchi. I think the FDA did a very poor job of communicating what they needed for this to be successful on 510K pathway. If the company gets IND for internal use trial in Q1 as they plan this will be on the path it should have been all along. PMA. This is also where the money is. This is biotech investing. Set backs are part of the landscape and in no way indicate a scam. Additionally if we get some more details on the partnerships TN discussed coming in the next couple quarters these recent set backs will be long forgotten. I understand traders leaving now, investors just need to take a deep breath. GLTA
CohBar Announces Approval for Listing on the NASDAQ Capital Market
Dec 13, 2017
OTC Disclosure & News Service
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NASDAQ Trading to Begin on December 15, 2017 Under Existing Ticker Symbol CWBR
New FDA guidelines for 510k could be big win for ARCH.
Yet despite manufacturers being able to demonstrate that they meet these consensus standards, a manufacturer is required to demonstrate that a device is substantially equivalent to an existing, legally marketed device. But the predicate devices that new products must compare themselves to are sometimes 40 years old. FDA recognizes that such direct comparison testing creates burdens for 510(k) applicants, especially when many new devices are designed in novel ways, using more advanced technologies. It’s sometimes hard to identify sufficient, appropriate predicate devices in order to conduct testing. This can create an obstacle to certain kinds of innovation and lead to inefficiency in the review process with few, if any, benefits to patient safety. In fact, at times, it can make it less efficient for FDA to assure the safety of the device.
New Steps to Reform, Modernize 510(k) Review
To address these challenges, in the first quarter of 2018, FDA intends to publish a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence. This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more closely approximate the kind of novel technology we’re being asked to evaluate.
Under this new framework, device manufacturers could demonstrate substantial equivalence by meeting objective safety and performance criteria. These can include FDA-recognized standards, FDA-developed guidance documents, or a combination of the two, which embody the safety and performance criteria that new devices could meet to be cleared under a 510(k). This pathway would be available for pre-specified categories of mature devices – those for which safety and performance criteria that meet or exceed the performance of existing, legally-marketed devices can be identified. It will be outlined in new draft guidance that we are announcing today in the Federal Register and plan to issue in the first quarter of 2018. This approach will also make it easier for FDA to conform its framework for evaluating new products to international consensus standards where such standards exist.
The program will be voluntary, and manufacturers could continue to utilize the existing 510(k) pathways. It would apply only to devices for which 510(k) clearance is the appropriate pathway to market
CohBar Announces the Appointment of Dr. John Amatruda to its Board
I liked the idea of a solid mesh that dissolved into AC 5. Sounded like a perfect application for trauma wounds.
You are correct
Arch presenting at LD micro conference on Dec. 5th at 4:30. Hope we get an update from that.
https://www.ldmicro.com/events/presenter-schedule
Per their conference call. They company had met all up listing requirements and had started the process.
It generally takes 4-6 weeks to process a listing application. This time frame is variable and may be shortened considerably, if the application raises no issues and the company responds to staff comments.
Week 1. Company submits application for listing and NASDAQ listing Qualifications staff begins its review.
Week 2-3. Staff completes its preliminary review and prepares comment letter.Week 3-4. Company addresses any issues raised by staff.
Week 5-6. Staff completes their review and company is approved for listing
by these guidelines guessing they will announce up list in the next two weeks.
KSS, MD, PhD? @KSSMDPhD · Nov 17
A mitochondrially-derived peptide owned by $CWBR recently shown to abate completely any toxicity to cultured neuronal cells conferred by amyloid proteins. And at low therapeutic concentration. Next step: animal model
guessing this will be announced after Nasdaq uplist in a couple weeks.
Additionally they added it will be done this year.
Per conference call they are currently in the process of uplisting to Nadaq!
Details for the Conference Call and Slide Presentation:
Date: November 13, 2017
Time: 2:00 p.m. (Pacific Time)
Audio, Dial-in U.S. and Canada: 1-888-599-8667
Audio, Dial-in International: 1-719-325-2494
Conference ID# 643238
Slide Presentation – go to www.webex.com, click on the ‘Join’ button and enter Meeting Number 921656999 and Password Q3Call.
Actually all submissions are assigned a k number when submitted. FDa just doent make it public until it is approved.
If the company can maintain this price through the end of the year they should be eligible to uplist.
CohBar, Inc. to Announce Third Quarter 2017 Financial Results and Host Conference Call for Shareholders on November 13, 2017
Also familiarizes FDA with AC 5. Have to believe it will have positive impact on internal use decisions.
Great job. And thanks. GLTA
No. Ac5 is classified as a medical device not a drug. It will be listed on approved 510k devices. It's number should be between k172140 and k172160 when approved.
Nice find. I was unaware of them hiring him. Where did you find it? I looked him up on linkd In. He is showing he came to Arch in july. Interesting that Arch didn't at least update their website with this info.
Regis999 in your discussions with the company did you happen to discuss uplisting to Nasdaq? Seems at this price and with the companies potential it would be a no brainer.
Thanks for all your help.
Thank you Sir! Will do
I think NASH is their first target. IND planned for Q1
I actually just learned of the company yesterday. I have only done surface DD outside of what I learned on the call. I did buy a starter position yesterday. I do have a link for the call but it is on the subscription side of Stock Gumshoe and they consider it proprietary info so I don't feel comfortable sharing it. Sorry.
What I liked: The science is potentially life altering. They are the only company currently pursuing this angle through the mitochondria. They have a tremendous IP portfolio. Their officers appear to be 1st class. They have gotten to the point of be ready to start human trials with only raising 18 million dollars. That is pretty much unheard of. They did issue an s-1 in September for a little over 6 million shares at about 2.70 a share. So the price may pull back some from yesterday. I am not shilling for the other sight but Dr. KSS is unparalleled in his willingness to share his knowledge and answer questions pertaining to biotech. I have an oversized (for me) investment in ARTH which is how I found out about SG and Dr. Kss. He thinks this may be the most exciting company He has found in years.
I am curious. Where did you first hear about this company? Guessing you will have more SG people checking in here after yesterday's conference call.
Doesn't appear there is going to be a webcast for tomorrows presentation either.
Welcome Black Doggie,
Valid question. Not sure if the company is required to announce a delay. I too suspect not, although some here would argue it is a material event that would trigger an 8k. Some companies do announce delays. CAPR just announced that FDA said their drug application may work but the company needs to do more work to prove it. In the case of Arch Dr. Norchi just stated on the 11th that AC5 is under active review.
Substantive Review (including Substantive Interaction and Interactive Review)
During Substantive Review, the Lead Reviewer conducts a comprehensive review of the 510(k) submission and communicates with the submitter through a Substantive Interaction, which should occur within 60 calendar days of receipt of the 510(k) submission.
The Substantive Interaction communication is typically:
•an email stating that FDA will proceed to resolve any outstanding deficiencies via Interactive Review; or
•an Additional Information (AI) request which places the submission on hold.
Interactive Review
If the Lead Reviewer chooses to continue with an Interactive Review, this means the Lead Reviewer has determined that any outstanding deficiencies may be adequately addressed within the timeframe set by the Medical Device User Fee Amendment of 2012 (MDUFA III) performance goal for a 510(k) (90 FDA days) and that the submission will not be placed on hold. The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as:
•Email
•Telephone Call
During Interactive Review, the Lead Reviewer may request additional information from the submitter, who may either send the information to the Lead Reviewer directly or to the DCC. Note: During Interactive Review, any information submitted to the DCC must include a valid eCopy
My guess is since Dr.Norchi made sure to say it was in active review that the submission will fall into the 90 day time frame.
This is not a yes or no answer but hope it helps.
Appears the market is focusing on the " may work" and not the " needs to do more work"
In the immortal worlds of Monty Python. " winks as good as a nod, say no more say no more!"
I am not so sure we will hear anything then unless they have approval in hand. I think TN is waiting for approval before anything else new is divulged.
Agreed on both counts. With approval in hand I think a lot of other milestones spead up.
Less than 3 weeks until 90 day FDA window. Fully expect to hear clearance in October.
They are presenting as we speak. No webcast available for this one.
I could be wrong but doesnt look like there is going to be a webcast of tomorrows presentation.
I respectfully disagree. Dr. Norchi was in charge of a 4 billion dollar fund. There is no way IMO he has not made people in that circle aware of Arch. I believe that group is watching and waiting for one of the afore mentioned metrics to be met and then will buy in with gusto.