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I have never commented on this. Many of my clients have academics/docs on their advisory board. It's not a big deal but it still helps when they are from a prestigious university/clinic.
Yaaaaaaaaaaaaaaaaaawn...........
No progress? You mean no progress in your nauseatingly repetitive posts?
"Chez moi"? Who are you trying to impress?
La culture, c'est comme la confiture, moins on en a, plus on l'étale!!!
Those who think that Isopet is a hopeless distraction are either shortsighted or really stupid.
"..question those who post questionable or outrageous posts."
You have been quite soft on your buddy SC8, despite his outrageous posts.
"How would I know MK omitted a critical consideration like genotoxicity in draft IDE application?"
How many brachytherapy devices have genetox in their FDA applications?
"Gotta keep things real"
Previous projections were made based on the need of containment data only (Phase I). The genetox was mentioned after the FDA saw the preliminary containment data.
The Therasphere approval package did not include genetox data. RDGL could not have anticipated it.
You can only use available information to make projection. New info, new projection. This is how things work.
Many on this board are too optimistic though and projections are often not realistic.
Realistic time frame based on most current information:
August: Meeting with FDA to discuss genetox protocol
September-October: CRO runs genetox assays (In vitro AMES and micronucleus assays; maybe in vivo micronucleus assay but I doubt it). RDGL Submits preliminary results to FDA and requests meeting
November: Meeting with FDA + CRO generates report
December: Final IDE is submitted
"A meeting with FDA means they flagged something in the genotoxicity protocol requiring a meeting discussion to talk things through"
Once again you are exposing your ignorance of how meetings are being scheduled. You obviously have never submitted anything to the FDA.
"La culture, c'est comme la confiture, moins on en a, plus on l'étale"
To cure: to relieve (a person or animal) of the symptoms of a disease or condition or to restore to a healthy condition.
Treatment: medical care given to a patient for an illness or injury.
A treatment may not cure the disease.
Thus Radiogel/Isopet is both a treatment and a cure since it has been proven effective!
SC8: Before playing with words, please make sure you know what they mean...
The AMES and in vitro micronucleus assays can be completed in 10 days. If RDGL gets the ok in August the assays could still be completed 3Q. When pushed, CROs can generate reports very quickly. IDE filing and approval in 4Q is still possible.
Genetox assays are fairly standard and can be run in parallel. They shouldn't take more than 2 months. Since they working with a CRO, the reporting should be straightforward, unlike with JHU.
"without a clear path forward"
Is there that much fog in your head? No wonder you can't tell the difference between facts and the figments of your warped imagination!
Your obviously never interacted with the FDA.
Have you ever submitted preliminary results?
I have...
Same old recycled garbage. By now it really stinks.
RDGL summitted preliminary data to the FDA and got feedback.
Submitting the final report is only box checking now.
Genetox was not included in the TheraSphere approval package.
https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200029B.pdf
"What matters is outcomes of clinical trials"
Indeed. An inferior product may well have inferior results. Game over. Time will tell.
And here are some important product features I obtained from an expert:
"...the radionuclide yttrium-90 is great, but the particle size of the Y-90-spheres is unfavorable for achieving a uniform biodistribution in target tissue. If you inject this BioGlue product into a tumor, you will achieve a bolus—a compact ball of glue and spheres. It won’t spread into the tissue matrix, since extracellular fluid channels in living tissue are less than a micrometer in diameter (and the spheres can be 20 to 40 micrometers in diameter). A bolus of glue and spheres presents a poor, non-uniform dose distribution to the tumor tissue."
This is how BAT-90 is prepared. It uses 2 commercially available products:
BAT-90 preparation and administration. For obtaining 1.0 ml of
BAT-90, 185 MBq (5 mCi) of 90Y microspheres (SIR-Spheres®,
Sirtex Medical, Bonn, Germany) were injected into 0.3 ml of
surgical sealant (BioGlue®, Cryolife Inc.) using a 5 ml dose syringe,
properly shielded in order to avoid possible 90Y contamination;
normal saline was added up to the final volume
Their focus is on liver and breast cancer. Mayo guided RDGL to thyroid cancer. It may take a while until there is real competition for the same tumor type.
I find it funny that the folks at BetaGlue call Y-90 a pure beta emitter! I guess they are deniers too...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9463933/
Running the study in Georgia means they probably didn't have the type of product qualification needed for a US based study. I came across a similar case where a company was contemplating conducting a study in Bengladesh. It would not have accelerated the US program. It was a feel good and nice to have study to justify the spending of a US clinical program.
Whatever results they may have presented may actually be a boost for RDGL.
Not necessarily so. The EMEA (EU) and PMDA (Japanese FDA) can have stricter criteria for certain parameters.
BetaGlue is currently not a RDGL competitor for the US market. Depending on their non-clinical dataset they could be far behind.
The human study is run in Tbilissi, Georgia. Obviously they did not have to file an IDE. The barrier to entry to human trials is likely much lower than in the US.
No. It was more like out of the park. McGwire on steroids...
Had a dream last night. Suddenly RDGL PS went through the roof!
May have been triggered by the late night French pâté and cheeses...
Yaaaaaaaaaawn
"Nothing has changed" ?????
So many things have happened over the last year and nothing has changed? Are you paying attention?
Yaaaawn.
Your Occam still sucks. Time for some sharpening.
Yaaaawn
No worries here. RDGL is doing much better than some others: https://www.fiercebiotech.com/biotech/2022-biotech-graveyard
"No update for almost 2 months" is not true. The last update was May 1st, so only 1 month has passed. And we got one today. Several activities are on going. That is not necessarily zero progress. We know what these activities are.
Yaaaaawn....
RDGL sent preliminary containment results to the FDA, which were discussed at the meeting. Are you paying attention?
I have sent preliminary data to the FDA. Have you? If not, then you don't know what you are talking about.
“TREMENDOUS DOUBT”
2 IDE drafts reviewed. Major concern (containment) addressed. RDGL has been making progress every months. So why should there be TREMENDOUS doubts? Please explain.
1. It's not up to RDGL to write the report. JHU has to write it, most likely under the supervision of the GLP consultant. RDGL is only involved in the review.
2. Phase 2 is NOT a dosimetry study.
Conclusion: You don't know what you are talking about.
The preliminary containment results were discussed at the last meeting with FDA and the issue was put to bed.
The on-going study is not a dosimetry study.
Are you paying attention?
Out of curiosity, how many GLP-like reports for regulatory submission have you ever written?
JHU has to write the report (not Dr K) and they are not a CRO who does it for a living. So it will take time. Add to it the multiple rounds of review and this will take at least a month.
It is not a small task.
The winning team, indeed!
Do not despise these small beginnings, for the LORD rejoices to see the work begin...
Zechariah 4:10 NLT
IDE approval soon!
Don't be too hard on RDGL.
We just submitted info to the FDA clearly stating that form A is unstable and that we are developing form B. Their response was: "Which form are you developing?"
We promptly and politely answered the question (again).
So they are not always the most astute...