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Meaning what?
EasyE, unfortunately w the shares coming in..I think we will be lucky to maintain 0.28-0.30
I doubt that the meeting will improve sp..But hopefully I am wrong
Its interesting that someone spends most of his time bashing this stock..Literally...Like he or she has nothing better to do
Dont get me wrong, its nice to see different perspective about it..But continuous bashing is just annoying..Hopefully you have a better more purposeful life than that..otherwise its just pathetic
Now, going to learn on how to add this guy to ignore list
If anyone can translate the total addressable market of CV007 and CV008 to profit and market value of CVSI, please do not hesitate to share
i understand there will be a lot of assumptions..including number of shares..But would be nice to see one or two estimate
I think we could have brought in someone with more extensive experience in CT setting...BUT this is by far the best news I have seen in past couple months...
The other news - about DOD or World No Tobacco Day are a joke. LOL
Only copied pasted relevant stuffs. I hope this is for real as I am terribly dissapointed to get in big time at $0.52. Pretty sure he is being brought in to help with CT of CV007..
https://www.linkedin.com/in/stephen-schmitz-md-mph-48a5873/
1. Medical Director, Global Pharmacovigilance
Company NameLantheus Medical Imaging
Dates EmployedDec 2008 – Sep 2012 Employment Duration3 yrs 10 mos
LocationN. Billerica, MA
Responsible for overseeing all pharmacovigilance activities for all marketed products and clinical trials
Oversee the Drug Safety CRO who holds our safety database.
Led a successful MHRA pharmacovigilance inspection and reinspection
Supervise the Associate Director, PV Operations
Develop a comprehensive, systemic approach to health hazard assessments and risk assessment related to product quality issues
Collaborated with clinical group on safety assessment of Phase III clinical trial
Respond to medical information queries and develop medical information contact for numerous products
Perform weekly medical literature searching for PVG and clinical development.
Serve as medical monitor for Phase IV study
Develop protocols for retrospective studies using a large hospital database.
Support the marketing effort through educational programs on product safety targeted for health care professionals
2. Stryker Biotech
Director, Clinical Development and Medical Affairs
Company NameStryker Biotech
Dates EmployedSep 2007 – Jul 2008 Employment Duration11 mos
Responsible for serving as medical monitor for Phase I and III studies in medical device and biologic. Specifically, serve as medical monitor for a Phase III trauma study, for a Phase I study in degenerative disc disease of the lumbar spine, and oversee Investigator Initiated Trials.
Support the Pharmacovigilance group by reviewing all serious and non-serious adverse events and product complaints, and working with Quality Group on trending of product complaints.
Support Sales and Marketing division by providing medical information summaries
Author clinical and safety sections of Investigator Brochure updates, protocol amendments, annual reports, periodic safety update reports, and other regulatory submissions (e.g., PMA)
3. Averion Inc
Vice-President, Medical and Regulatory Affairs
Company NameAverion Inc
Dates EmployedMay 2004 – Sep 2007 Employment Duration3 yrs 5 mos
Responsible for directing and coordinating all aspects of medical affairs (medical writing, safety/pharmacovigilance, data monitoring committees); directing and coordinating timely regulatory submissions, providing regulatory guidance at all levels of product development; interfacing and maintaining relationships with domestic and international regulatory authorities; training in-house staff in medical issues and provide internal medical consultation to Averion; reviewing clinical documents and publications; and participating in internal, Client/Sponsor, and scientific presentations.
Current client base includes medical device companies (50%) and drug (25%) and biologics (25%) companies.
4. Transkaryotic Therapies, Inc
Director
Company NameTranskaryotic Therapies, Inc
Dates EmployedMay 2002 – May 2004 Employment Duration2 yrs 1 mo
Responsible for overseeing safety in the clinical trial setting and post-marketing (Europe). Worked closely with clinical affairs in development of phase II/III protocol for Hunter syndrome.
Actively participated in clinical team in preparation for an Advisory Committee meeting for Replagal®.
Critical contributor to the project team for I2S, an enzyme replacement therapy for Hunter syndrome.
Authored solely or contributed to annual reports for several products, the Periodic Safety Update Report (PSUR) and Complete Response for Replagal. Communicated with FDA in written and oral form on a regular basis. Worked with Medical Affairs in the development of pre- and post-launch materials for Replagal®.
5. Biogen, Inc
Associate Medical Director
Company NameBiogen, Inc
Dates EmployedMay 1998 – May 2002 Employment Duration4 yrs 1 mo
Responsible for overseeing post marketing safety database of Biogen's marketed products; providing medical oversight to investigational new drug in phase II and phase III (natalizumab); developing and implementing a global medical information system; supervising the manager of Medical Infomatics and Data Specialist function; writing a variety of safety documents for global dissemination (e.g., standard medical letters); preparing regulatory reports for the US and Europe; coordinating special epidemiologic projects using large, retrospective databases.
Honestly I dont see this going up. By the time June 15 comes, they have new distribution of shares which will place more pressure on the sp..
While the June 15 carries no significance on the sp or future of the company unless they do manage to get good CT results or get approved
This is insane..slowly dropping to God knows where
Looks like CVSI hired this guy in 2015 in preparation of KY Initiative.
https://www.linkedin.com/in/josh-hendrix-93018b2b/
Does anyone have any idea who the lead scientist for 007 is? Cant seem to find the nformation.
DB, as far as I am concerned institutional does not buy anything under $10 let alone $1..
I doubt the Pre IND meeting would move this stock a lot..Thats why it really bothers me that they issue options based on completion of the meeting
Results of P1, 2 and 3 trials would however carry a lot of significance..They have multiple distribution without the results of clinical trials..
PreIND meeting announced mid June
Could be 2018/2019...See slide #22 It shows the timeline for CT. Phase 1 is supposed to start this year. Phase 2 in 2017/2018...and P3 is tbd
http://cvsciences.com/wp-content/uploads/2017/02/CVSI-Deck-Noble-Conference.Feb2017_FINAL.pdf
Lets just hope they have a blow out number. Things are not looking good short term at the moment
Micro, FDA approval is not gonna come until next year
Nvm, just caught up on the situation
DB what does this have to do with CVSI...just curious
Me too, more than I should have to say the least
Anyone heard anything on CV007 meeting w FDA that should have been done at the end of Q1?
Ideal scenario, 3-4 days prior to ER, CVSI reports that CT P1 starts shortly. then ER shows blow out earning. Then Fed legalization came out in favor lol
There was a time this was $200, not fundamentally driven though
Timeline? At what price do you think profit taking starts taking place?
NO worries. CVSI typically has wild swing before it breaks out. I think what happens today and perhaps Thursday could just be a sign that a move up is coming.
So, according to the information currently available, 007 patent is not available out there. I think that is just due to the status of the patent filed being "provisional" (http://cvsciences.com/wp-content/uploads/2016/09/CV-Sciences-CEO-Letter.Sep14.2016.pdf). I looked up patent associated with CV Sciences or Michael J Mona, or CannaVest and was able to find the following:
http://patents.justia.com/inventor/michael-j-mona-iii
Three results came out from this link. You can click the first one and see that they actually filed provisional patent first for the extraction of CBD oil and then filed the non-provisional patent at a later date.
Under the Description section: This application claims the benefit of application Ser. No. 14/791,184 filed on Jul. 2, 2015, which claims the benefit under provisional application No. 62/020,053, filed on Jul. 2, 2014, and the contents of the aforementioned application are incorporated herein by reference in their entirety.
I was a bit concerned about the fact that they had to file provisional patent. BUT given that there is precedent, I believe there is nothing to worry about on this end.
Last I checked, they only filed "provisional" patent...which based on my limited understanding is not reviewed by uspto and will not be searchable
Per wikipedia
A provisional application, as such, is never examined by the USPTO, and therefore will never become a patent on its own (unless the provisional patent application is later converted into a non-provisional patent application by the applicant, and then the application is examined as a non-provisional application). The provisional application is also not "published", but becomes a part of any later non-provisional application file that references it, and thus becomes "public" upon issuance of a patent claiming its priority benefit.
I am not aware that this is a fast track application..I would think we would get a boost from either ER or congress decision on the removal of CBD from schedule I
On 007 side, I am not impressed w how the criteria were set up for mgmt performance on 007. Its all seem too easy for mgmt to get the options. 50% upon start of P1 Trial
Are you aware of any discussion being done with Whole Foods?