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And what do you want RDGL to do while waiting for JHU to run the rabbit studies? Twiddle their thumbs?
"if rabbit containment is less than 100%, safe to expect further animal testing will be suggested". How do you know? This is just another wild speculation from someone who has never submitted a single drug/device application to the FDA.
IDE submission may be late 2Q23 or early 3Q23. Assuming IRB approval of the human protocol in the same time frame, first patient in (FPI) could be early 4Q23.
Many companies advertise their pipeline online.
I've been in the drug discovery business for 20+ years. Many projects were called next generation xxx, even at the early stage, years before IND or NDA. There is nothing misleading about it. If it's ok for Merck, BMS, or J&J then it's ok for RDGL.
"Next" is not referring to timing wrt to approval but to a new development in radiotherapy. Many drugs are called next- or new- generation something to differentiate from existing therapy, even after market approval.
"RDGL rebelling against that advice and trying to bully FDA".
When did they rebel and bully? They are doing exactly as advised.
FDA suggested EFS IDE path: They complied
FDA requested dosimetry meeting: They complied
FDA requested additional containment data: They are complying
When did they push back and not comply?
So what?
IDE approval will be end of 2Q23 or early 3Q23. Could be earlier if JHU inoculates the rabbits before Christmas.
Hopefully the VX-2 study has been approved by the JHU IACUC and the vets have ordered the rabbits.
There isn't much accessible information on the JHU Research Animal Resources Webpage:
https://researchanimalresources.jhu.edu/
At least there is a pic of a rabbit so it must be a common species kept in their vivarium.
There is a note at the bottom right on GLP studies. It explains the need for an outside consultant/monitor.
Let's not forgot where we are:
BDD denied but FDA suggested EFS IDE which increases interactions and will speed up development once in the clinic.
Draft IDE and clinical protocol have been submitted and FDA feedback received.
Requested preclinical containment study protocol has been approved by FDA and is under review by JHU IACUC. From inoculation to finish the study is about 1 month (assuming all rabbits run in parallel).
Unless there has been another request from the FDA that was not communicated, the IDE should be ready to be submitted once the study report has been completed.
RDGL may still want to have a meeting with the FDA to review the data before IDE submission to ensure no surprise. It will cost about 1.5 month but that is ok.
I've gone through many (IND) submissions with the FDA and given how things are moving along IDE denial is very unlikely.
I predict IDE approval 2Q23 or very early 3Q23. We could have first clinical data by mid to end of 4Q23. The nickel days will be long gone by then!
Past submissions were for marketing authorization. RDGL is now applying for IDE. Apples and oranges...
The market is irrelevant for IDE approval.
The market is irrelevant. Only the FDA matters. Give me a reason why the IDE will not get approved.
Again, they were trying to get market approval which is a high bar without clinical data. Had they started with an more traditional approach (IDE + clinical trials) they could be filing for market approval by now!
The "one day" is coming soon. It is highly unlikely that the IDE will not be approved.
So IDE was never rejected since this will be the first IDE ever submitted.
That was not an IDE submission but a submission for marketing clearance, 2 very different submissions.
No submission between 2016-2017:
https://www.itnonline.com/content/advanced-medical-isotope-corp-progressing-toward-fda-y-90-radiogel-device-clearance
No submission between 2014-2016:
https://www.prnewswire.com/news-releases/advanced-medical-isotope-corporation-files-a-de-novo-submission-for-y-90-radiogeltm-device-300013648.html
So, lots of talk with the FDA but no IDE submission. Technically, IDE has thus never been rejected.
Dr K has brought us very close to submission. JHU IACUC review of the protocol is on Thursday (Nov 17th). Hopefully RDGL/JHU have selected the GLP consultant and are ready to start the study after approval.
Found this:
https://ca.finance.yahoo.com/news/advanced-medical-isotope-corporation-completes-132800741.html
It doesn't look like an IDE submission so if there ever was one it must have been before 2017.
IDE has not been submitted so there is no denial or approval.
To those who have been following RDGL long enough: has there ever been an IDE submission? If so, when?
The containment study is relatively simple if the primary endpoint is PET imaging. I coordinate more complex studies for some of my clients.
IDE and BDD applications are 2 different things. BDD denial has no baring on IDE approval. The BDD application may have been premature given the lack of clinical data.
"FDA did not approve RDGL to do human test is due to RDGL has not provided enough data of animal treament to prove Isopet's safty, right?"
Wrong. FDA is requesting additional containment data on RDGL and not safety data. Although possibly related, these are two different types of studies.
Isopet is part of the business and news about the business is no distraction.
I mentioned shortcomings but where did I acknowledge lack of focus?
The next 6 months will be exciting and the culmination of many years of waiting for all the longs on this board. The tortoise RDGL is finally approaching the finish line of the qualifying race. Slowly but steadily it has forged ahead despite its own shortcomings and the naysayers who have repeatedly forecasted its doom.
After a short rest it will enter the next heat and show it can compete at a higher level before lining up for the final race.
To apply for HUD, the incidence of the tumor type should be < 8,000 cases/year.
Some included here could be candidates: https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors
TheraSphere was granted Humanitarian Device Exemption (HDE) in 1999: (https://www.accessdata.fda.gov/cdrh_docs/pdf/H980006A.pdf).
Effectiveness is not a requirement for HDE application: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption
JHU will run the containment study and RDGL will submit the IDE. What else do you need?
Didn't they submit a draft IDE as part of the EFS paradigm?
Isn't that what they are working on?
Here: https://web.jhu.edu/animalcare/
If the protocol was submitted prior to Nov 1st then the review meeting will be Nov 17th.
There is already solid VX-2 rabbit data available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996238/.
So it's not clear why the FDA wants additional containment data. I understand now Dr K's frustration.
The JHU IACUC meeting to review new protocols is on Nov 17th. We may get an update after that.
Since the VX-2 inoculation is already IACUC approved I hope they have already started.
It will depend on the recruitment rate. They will need up to 12 patients for the EFS (Phase 1). Maybe less if the results with the first 6-8 patients are looking good.
In an EFS paradigm there is constant interaction with FDA and they could decide to accelerate initiation of the pivotal trial (i.e. skipping Phase 2). Imagine what this would do to the PPS!!!!
Have you ever been involved in an oncology trial? Obviously not. I just reviewed yet another Phase I protocol. No control. For another program we are entering Phase 2. No control.
A "controlled" studies and a study with active control are 2 different things...
You can keep your merde!
"Without a control, it's not science". What are you smoking? There is no control in the rabbit study.
In most oncology clinical studies there is no control. So it's not science? What is it then?
When did the FDA suggest the rabbit study?
Tu n'arrêtes donc jamais!
You are wrong. RDGL has provided containment data to the FDA. Most likely they were too heterogeneous (different species, tumor types etc...) and possibly not quantitative enough for regulatory submission. Thus the need for the controlled rabbit study.
I have been on projects were they was a disagreement with the FDA. Our experts thought we had a solid case. But the FDA still required us to run a study that we (a major pharma) were trying to avoid.