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Here is a reply about the word "traditional" in the press release-
From Sree Koneru
Thank you for your message. The 510(k) that was filed does combine indications from the previous 510(k), which is why we are asking for "expanded" indications. The word "traditional" in the 510(k) is just to indicate the type of application prepared, as there are only three types. Seeking expanded indications automatically requires a "traditional" 510(k), since the other two types are for device modifications etc.
From the press release,".bielcorp.com is pleased to announce that a Traditional 510(k) Premarket Notification for ActiPatch® was filed today"
It says nothing about an expedited review. I'll email Paul and Sree for clarification unless somebody can point me to info saying it's expedited. If it's a regular 510k it will be a 90 day review, though I guess it could be less since they are now familiar with Actipatch.
I prefer not to wait 8-9 months to submit that 510k though.
Entry in Sept, picks for the challenge in Nov, 90 days for them to review, then file the expidited 510k (30 days?) I'd like to see it submitted ASAP, hopefully when the general clearance 510k is out of the way, but we have to do it the way the FDA recommends.
Medical devices at any stage of development are eligible. Feasibility and the potential impact of FDA participation in development to expedite marketing of the device are other factors that will be considered.
What to Expect After Applying
The goal of the Challenge is to expedite development and review of innovative, safe and effective medical devices to help prevent and treat opioid use disorder. FDA review divisions and management will work closely with developers of devices accepted into the Challenge. In most cases, applicants will eventually submit one or more formal applications to FDA, such as an Investigational Device Exemption (IDE), De Novo, 510(k), or Premarket Approval (PMA). The review of each of these applications will be expedited to minimize review times. The regulatory standard of demonstration of reasonable assurance of safety and effectiveness still applies.
FDA will notify developers whose applications are selected for the Challenge directly. The agency intends to issue a public announcement about applications selected into the challenge and will obtain consent from device developers before publicly disclosing any proprietary information from their application.
If selected into the Challenge, the process will begin with the collaboration phase, an agreed-upon period of interaction (not to exceed 90-days) the goals of which will be: 1) to create a mutual understanding of the medical device, the patient and user needs, the important risks and benefits; and 2) to establish the regulatory pathway forward.
Application Submission Deadlines and Decisions
Submit your application electronically to CDRH-Innovation-Opioid@fda.hhs.gov on or before September 30, 2018. The Agency intends to announce applications selected for the Challenge in November 2018. As many meritorious applications as resources permit will be selected. Following completion of the review, applicants will be notified of their application status with the following possible outcomes:
That would be around 9 months out for Recovery Rx. I hope they submit the 510k before acceptance into the challenge, we have to wait to see if the FDA is ok with that, can't piss them off at this stage.
From Sree Koneru
Thank you for your e-mail. We are in the process of seeking guidance from the FDA on the appropriate time to submit the RecoveryRx 510(k), with respect to the Innovation Challenge. The Allay study is going strong and we expect a timely completion this year, however we do not have additional information on when the 510(k) will be filed. Any updates that we have regarding these two matters will be made publicly available via a press release.
Good link Gramps!
Recovery Rx
From Sree Koneru
Thank you for your e-mail. We are in the process of seeking guidance from the FDA on the appropriate time to submit the RecoveryRx 510(k), with respect to the Innovation Challenge. The Allay study is going strong and we expect a timely completion this year, however we do not have additional information on when the 510(k) will be filed. Any updates that we have regarding these two matters will be made publicly available via a press release.
Timing for the Recovery Rx 510k. I wanted to find out whether they were going to submit a 510k before, during or after the FDA challenge. It turns out they are working with the FDA to find the best path.
From Sree Koneru
Thank you for your e-mail. We are in the process of seeking guidance from the FDA on the appropriate time to submit the RecoveryRx 510(k), with respect to the Innovation Challenge. The Allay study is going strong and we expect a timely completion this year, however we do not have additional information on when the 510(k) will be filed. Any updates that we have regarding these two matters will be made publicly available via a press release.
Hey, Art.
This from Paul K.
We are planning to submit both the 510(k) for post operative pain and an application to participate in the FDA's Innovation Challenge. The participation in the Innovation Challenge presents the opportunity to get an indication of use to mitigate opioid use.
We do not have a schedule yet for the Allay product.
Does that mean they will submit the 510k in September? Wouldn't they ask for a pre-submission hearing first? # months to gather entries and then 2 months review them. How long to definitively clear them after the challenge, days, weeks, months? I am all for submitting ASAP. I'll see if Paul can clarify.
With the unbelievable opiod problem it is hard to believe even with their poor cash position that they couldn't have cashed in on the coverage of this issue somehow. Any thoughts from someone with advertising experience? One small news story with a few parents who lost their kids to opioids to make a plea or something, put a face to it. You don't need to have someone set themselves on fire in a public place or anything, though that would bring attention ;) You have to strike while the iron is hot.
On deck
1. File 510k for general use
2. Minor or fluff PR
3. FDA response to general use 510k
4. ?
Hopefully 2 days till the General clearance 510k gets submitted and clearance 30 days after. I'm trying to nail down the when they plan on filing the 510Ks for post surgical use and Allay.
This is from Paul K.
We are planning to submit both the 510(k) for post operative pain and an application to participate in the FDA's Innovation Challenge. The participation in the Innovation Challenge presents the opportunity to get an indication of use to mitigate opioid use.
We do not have a schedule yet for the Allay product.
Hi, Art. What I'm want to find out is if they plan to file a 510k before entering, while entered or after being accepted. The answer is measured in months. I had shoulder surgery a few years ago. The port sites that were under the Actipatch closed up much quicker than the uncovered one. The post-surgical indication could be a massive opportunity.
I hope it goes down like that, toohot. The post op one, I don't know that they are going to file a 510k right away. They are doing the FDA Challenge and they are taking applications till the end of September.
This was a reply from Paul K.- Has the 510k for post-surgical use been submitted? No it will most likely be submitted into the FDA’s opioid mitigation program.
Does that mean it wont be submitted till Sept or Oct? IDK. I will try to get clarification from him.
A press release and the news would cause a drop, which is the best way to go. All at once. Then it's done. The way it is now with some people knowing, the stock prices goes down and we still have to go through the rest of the people knowing. It's always better to take your lumps right away