Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The phase 2 data may not be needed for the IDE. I don't think it was in the original study plan.
"The post-meeting focus is now on completing the final VX2 report..."
We will find out eventually.
I am going after the sequence RDGL has outlined in previous communications. They have rarely proceeded faster.
Clinical trial will not start before 4Q. Need IDE submission and approval, contract negotiation with Mayo Clinic and IRB approval. Best case scenario: 2+1+1+1=5 months from now.
Everything is lining up nicely though and the IDE will be approved soon.
I wonder what the new comments on genotoxicity are and if they are related to this 2022 publication:
Genotoxicity Associated with 131I and 99mTc Exposure in Nuclear Medicine Staff: A Physical and Biological Monitoring Study
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9139973/
Most likely RDGL requested the meeting after seeing the preliminary containment data. The FDA agreed and scheduled the meeting on an accelerated timeline (30 days) as they had when they reviewed the study protocol.
Per January update: Budget negotiation with Mayo Clinic and IRB review of the protocol.
It won't happen that fast. You are forgetting many steps. EFS will most likely be initiated 4Q.
got to keep it real
The "indirect containment studies" as he calls them were conducted many years ago at Batelle. No RDGL money was wasted as he claims.
It's all lies or total ignorance.
Most of my clients work in oncology. For many programs the target
I asked someone who knows a lot more about RadioGel and Vivos than most of us about some of his comments. His response was: "either complete ignorance or lies".
My timeline has been 2Q23 for submission of the final IDE. They are getting help from an experienced consulting firm with the study so it should be easy to get the report done before the end of 2Q.
Phase 2 is a dose response study so they needed a new set of rabbits. From the update the rabbits have been inoculated and the tumors are growing.
Non-clinical tumor growth inhibition (TGI) studies are typically 28 days. Again, from the update they already have robust TGI after 10 days so assume they will not need much longer. Phase 2 should be completed by mid-May.
RDGL may have requested the meeting after they got the containment data and the FDA may have scheduled the meeting on a 30-day accelerated timeline.
Next IDE submission will most likely be the final one.
The FDA has questions about containment and RDGL proposed the rabbit study to address them. That is all we know.
The claim that the FDA specifically suggested/requested a PET study in rabbits is not supported by any communication from RDGL.
The FDA only asked for an animal test in his head. All we know is that they had questions. It is RDGL who proposed an animal studies to answer these questions.
The FDA will not review drafts forever. The first one was probably lacking in many respects, which the second one hopefully addressed. If so, the next submission will most likely be the final one.
In an exchange I had with Dr Fisher he mentioned:
"The composite has been optimized for a dozen or more specific design objectives, including imageability with positron-emission tomography (PET) in combination with computed tomography (CT)".
So all claims that he is an "Y-90 Positron emission denier" are false.
And Vermillion, now Aspira Women’s Health Inc., went from $0.010 to $33 in 2009/2010. Nice jump!
Not crazy at all. This is going to the clinic.
Mayo clinic is NOT a business. It is a non-profit organization.
https://www.mayoclinic.org/about-mayo-clinic
And May, and June, and July, and September, and... will all be very exciting. The pace is accelerating. The PS will follow.
Early 2Q was my prediction based on a best case scenario which didn't materialize. Nevertheless, JHU is moving very fast so IDE submission in 2Q is still possible but RDGL would have to request the last meeting by end of April and get an accelerated meeting scheduled (30 days). If the meeting is granted on a regular schedule it will be held end of June. Add another month to submit the IDE and a 30-day review then approval would be by end of August.
I still anticipate FPI 4Q23 with a first read on efficacy in 1Q24. The EFS could be completed by 4Q24 if enrollment speeds up after the first 2-3 patients have been treated and observed. If all looks good by then the FDA could recommended moving straight to the PhIII pivotal study which would be a huge time saver on our way to market approval.
Agree. The path could not be clearer.
FDA had questions on containment and RDGL (not FDA) proposed a study to definitively address them. FDA agreed with the design and RDGL (JHU) is conducting the study. Once the study is completed a report will be generated and submitted with the final IDE.
Everything beyond this is FUD.
"failure to even start the additional testing that FDA suggested almost 15 months ago"
Once again, you don't know what the FDA suggested 15 months ago. At that time another meeting was agreed upon to discuss containment and dosimetry. So it is far more likely that the study Dr K referred to was something else. And we know that there are at least 91 other studies that have been submitted in the latest draft IDE. It could be anyone of these. Many of my clients have failed to run routine studies when about to submit INDs. It happens. Besides, it was RDGL who proposed a study to answer the FDA's questions. This implies that the FDA did not request a study at the first meeting.
A sharp Occam's razor will come to a different conclusion than yours.
Since I am allowed only one post per day: Go RDGL! IDE filing 2Q23!
Nor do they claim to be a medical journal... But how about the people they interview? Are they credible? That is the question you should ask.
I am only allowed one post per day. So that's it for me today.
IDE submission soon, likely end of 2Q IMHO. Go RDGL!
Cigar smoking isn't as bad as you are claiming it to be:
https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-020-00446-4
"Figure 1 presents the adjusted HRs for mortality from all causes among men who were cigarette and/or cigar smokers compared with never users, according to age group. This was elevated 10% among older current and former exclusive cigar smokers but was not statistically significant."
Congrats Sean!
SUMMARY OF SAFETY AND EFFECTIVENESS DATA for TheraSpheres from the FDA approval package: https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200029B.pdf
Study 7 on page 14: Biodistribution of TheraSphere in Rabbits. Looks like biodistribution was assessed from excised organs/organ samples (and I assume liquid scintillation counting), not by whole-body PET. Apparently this is an ok method for the FDA...
I mentioned that a while ago. Guess who on this board didn't believe it...
The Duke group has been at it for a while (at least since 2001): https://pubmed.ncbi.nlm.nih.gov/11245464/. And they are still not in the clinic... RDGL on the other hand is very close to IDE with a ready clinical protocol. Well done Dr K!
The FDA is working with RDGL to move this into patients. Why would they block it now?
The containment has been discussed at length with the FDA. RDGL doesn't seem to be too worried about it. By now they must have a good sense of what is acceptable and how the FDA will use the data.
By the time the submit the final IDE there won't much new in it. The containment topic has already been discussed at length and the report may only be a box-checking exercise at this time. We will know soon.
It looks like they submitted the nearly final IDE to save time. All they have to do after the meeting is to include the reports for the containment study and aseptic filling validation and submit the final IDE for approval. I highly doubt there will be a meeting to discuss the containment study.
For standard request ~ 60 days
For accelerated request ~ 30 days
So the meeting to get feedback on the draft IDE could be at the end of the month.
Each day we are moving closer to final IDE submission. Despite his shortcomings Dr K has done a great job getting us here. But this is only the beginning for RadioGel. Things are about to get really exciting. Fasten your seatbelts!
Not really. The BDD accelerates the review process and saves some time.
Transitioning directly to phase 3 saves a lot of time!
Once clinical data are in, RDGL can reapply for BDD.
I am hoping for a direct transition from the EFS to the pivotal study (Phase 3) which is realistic given the benefit/risk profile we have seen in animals.
Each days brings us closer to IDE approval. Get ready for an exciting 2023 and an even more exciting 2024!
And keep in mind he had no experience in the drug/device development business. He is also not a youngster.
I do this for a living, and it's not easy.
But whatever obstacles he has faced, he found a way out. He deserves much more credit than blame!
Indeed. 91 finalized reports don't happen overnight.
One of the issues with the previous containment studies might have been with the archiving (notebooks) and reporting which were likely substandard and wouldn't pass auditing. Thus the need for a GLP-like study that will satisfy all regulatory agencies around the world (the Japanese PMDA is often more strict than the FDA), since containment is a key feature of RadioGel.
Getting a 2nd review of the draft IDE by the FDA without the containment study is a good indicator that it won't be a show stopper given the previous data that demonstrated tumor containment at post dose (by PET), 48 h (by liquid scintillation counting), and 10 days (by microCT scan of YPO4 particles).
In all my filings with the FDA I never had even one review of a draft IND. They all were direct submissions. With 2 rounds of review pre-submission and if RDGL follows FDA recommendations (which they are doing) IDE approval is 100% guaranteed.
The pace is picking up. We are getting close to the goal line.
Agree! IDE submission could well be 2Q now, if nothing unanticipated happens:
Feb: Rabbit study dress rehearsal
Mar: Rabbit study initiation
End of Mar/early Apr: Meeting with the FDA (60-days from request on a standard timeline)
May: Rabbit study and aseptically fill validation completed
June: Reports available and IDE submission
If not 2Q, definitely 3Q.