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Pertinent-information-is-NOT-available-on-their-website.
o Status of 510K submitted in August, relative to 90 day expectations
o Sales & revenue projections relative to additional outlets recently announced
Personally, not satisfied relative to generally acceptable business practices relative to Sales & Revenue projections, as well with respect to future markets IE: 510K
If-enough-share-holders-contact-the-company and suggest more transparency with respect to 510k status, maybe we would all benefit.
Also, would prefer the company provide sales projection numbers relative to recent additional sales channels being brought online
The intent is to gain consensus that the company begin acting like what would be expected from a company with a viable business model
Ideally the company would begin sharing sales and revenue projections, rather then leaving so much to speculation.
Fundamentally of the opinion that the lack of movement in the valuations relative to what should be spectacular news is a function of historical track record of not being transparent enough.
If this company wants to gain credibility then try to provide investors additional transparency.
Suggest institutional investor opportunities would also be improved if improved consistency were to be established to reduce some of the speculative nature of the PR campaigns.
Have-contacted-Paul-on-Multiple-occassions
He is quite willing to respond where feasible, but he has marching orders with respect to how transparent the company wants to be.
Also, not interested in boasting "urination contest" with respect share-holder status.
Transparency-bias-if-potentially-positive
Trying to rationalize why even communicate the 510k filing if in the companies best interest to not be transparent about the progress or status.
As near as can tell, there is a bias to PR the heck out of positive news, but no news with respect to expectations regarding the 90 days.
Not trying to insult anybodies intelligence, trying to understand company motivations with respect to lack of information on the status of the 510k filing given the amount of speculation.
Looking-for-more-transparency-on-status-of-510k-filing
Company seems willing to share details about the filing of the 510k, but seem rather quiet about the status, especially considering there was the 90 day expectations.
Leaning in the direction they seem willing to share positive news, but may not be as willing to share potentially negative news.
Not suggesting what the status is, just would prefer the company provided more transparency to shareholders given the critical nature of FDA status for the future of the business model.
Trying to understand whats the harm in transparency?
Agreed, the number itself is not viable until after a decision is made. The fact the company is unwilling to share the information is what is suspicious given past negative history.
Why would the company not be will to share, whats the harm?
Agreed, there are significant gaps in 90-day expectations and what is being presented as the reason why no decision available within the 90 day period.
Encourage others to inquire with company about status of 510k and specifically what is the submission number?
Can share what response I received from company PR manager:
??> "Can you share the 510k number being referenced?"
AA> "The company has asked not to."
Aug-06-510K-submitted-assuming-ReClassification
That was the rational from the Legal Counsel. Submit assuming reclassification will occur, why else submit the 510K?
Now the optimists are suggesting reclassification restarts the decision counter. IRRATIONAL
Was-expecting-more-history-for-ActiPatch but nothing? Thought there was previous submissions and decisions?
Dissapointed-in-lack-of-awareness-knowledge Facts regarding the process timelines are in the link shared. Day-0 was supposedly back in Aug-06-2015
Approaching-Day-100-Missed-MDUFA-Decision-period?
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm#decision
Why-ActiPatch-Not-Listed-Here www.510kdecisions.com/device_names/index.cfm?fuseaction=list&limit=ac
Why-510k-Not-Listed-Here www.510kdecisions.com/applications/index.cfm?fuseaction=list&contact=ANDREW%20J%20WHELAN
Public-Example: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K022404
Example-K022404-510k
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K022404
What-is-the-510k-Number?
Then go here:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Maybe-Final-PR-Pump-and-Dump-Before-BK-or-Reverse-Split
Suggest-Ask-Company-Confirm-Profitability-Q12016
Seems very reasonable to expect an answer
--> pknopick@eandecommunications.com
TOXIC-DILUTION-ELIMINATES-ANY-POTENTIAL-UPSIDE
Agree Toxic Dilution has killed any potential
Not benefit shareholders, pay family debt with near term revenue influx. Dilution has to be reversed and records indicate no plan to change current course, If there was confidence in near term revenue stream, would not be filing documents to increase shares
Dillution with no plan to change course
Agreed, dillution killed all potential
"To date, FDA has not cleared an SWT device for OTC use
and, as a result, has limited the reclassification in this final order to prescription use devices.
However, if FDA receives a marketing application in the future for an SWT device indicated for
OTC use, FDA would make its classification decision regarding such use at that time."
Point was: What if ActiPatch was high rated US product
Relative to #2 CA product Penetrex in US having 7K reviews
Not sure have ever seen Media coverage/adds for Penetrex in US
Again, point is if you extrapolate #1 in CA into US, what would be the volume potential, anything close to the 7K reviews? Which must extrapolate into 10's of thousands of sales?
What if US ratios for similar products were to be achieved.
Interesting extrapolation if products were available to US consumers relative to number of reviews for products within same category.
http://www.amazon.com/Best-Sellers-Health-Personal-Care-Joint-Muscle-Pain-Relief-Treatments/zgbs/hpc/15316471/ref=zg_bs_nav_hpc_5_3763741
IE: 7,686 reviews in US for the 2nd rated product in CA, that only has ~50 reviews in CA.