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Next headline: “FDA cheers CYDY results, extends existing PE to one year and doubles required patients.”
https://www.biopharmadive.com/spons/five-recent-developments-radically-re-shaping-new-drug-commercialization/565612/
Interesting article as we think about commercialization.
Samsung deal.
I agree. My hope is keep cancer and HIV. Sell prostate.
News!
New PR the reason for the delay in TNBC trail perhaps? Cancer applications of new test were mentioned.
It has to be so hard to plan when the FDA keeps moving the goal posts. The uncertainty of the drug's performance is enough without the FDA flip flopping all over the place. I am sure NP is as frustrated as we are.
I don’t understand. Group C had 6/43 failures but 100% had complete suppression at 12-24 weeks. Isn’t that inconsistent?
If cancer works......
Here are the annual new cases in each of the 8 new experiments:
Cancers
Melanoma 91,270
Pancreatic 55,440
Breast 268,670
Prostate 164,690
Colon 97,220
Lung 234,030
Liver 42,220
Stomach 26,240
Total 979,780
If just 10% of these cases (97,000) per year go on leronlimab at $100,000 per year, that's $58 Billion per year in 6 years. That is our forest and it is a big one. The tree (I would say sapling) is how much NP and RP make. I prefer looking at the forest.
Bored, yes 100%. As Fine notes, small sample but response rate went up across all dosages. Pretty impressive if you ask me. Slide 7 bottom at 4:40 mark.
In today’s presentation, the story that, given the correct run in, 100% of patients responded at 700 mg, is quite remarkable. Has everyone digested this little tidbit?
If someone wanted to paint the tape, could they put is a .05 fill or kill sale?
Well said G2!
I think that until the FDA gets comfortable with the efficacy and safety of a drug, they keep their foot on the brakes, setting almost unreachable requirements. Now that they see the safety and efficacy, they are letting the brake off a bit. That was the evolution of both combo and mono trials.
I agree. My mental model is this is either really big or really really really big. Tough problem to have.
I understand. There is always risk. I was just trying to discern how much. I appreciate your perspective.
Great to know. I hope you and Dr RP are right. I just don’t want to let myself get crushed if it fails. Thanks for the input, as always.
I know, its just not PRO 140. What probability do you give PRO 140 being successful in human trials?
I agree Index and Saltz. As much as cancer is exciting, it is still just a mouse model. If I had a dollar for every mouse that got cured of cancer but humans didn’t, ....
Dollars are very close for combo and mono. Chase them first and then chase the mice.
I agree G2. Seems like the FDA is moving the goal posts again. They aren’t even done with safety for combo after how many years?
Seems like people’s ire that is directed at Nader should be aimed at the FDA!
So do you do a PIII across all CCR5+ cancers? Is that the pivotal? If so, is the PII colon study they are proposing necessary?
Just listened again. At 27:10, Dr RP said our proof of principle is TNBC. Then we will seek approval of the mechanism across ALL CCR5 CANCERS!
Wow!
FDA has target for approval of 510(k) applications of 90 days. Prostate test headed to finish line once filed.
I think one of the “good news” to come references will be good news from the FDA. BTD perhaps?
Noble Con slides. On the slide titled CD02 Pivotal (8:00 minute mark) last bullet point says “Rolling submission starts in Feb.” If that means last two sections filed in Feb., that would be awesome and an “under promise, over deliver” event for the naysayers to consider.
Sorry for the name typo, Misiu.
Musiu
Thanks for sharing. Great to hear NP is out drumming up investor interest. I agree, he works very hard and, I for one, appreciate it.
I think the important point is that, regardless if it is 6 or 60, if Leronlimab becomes SOC, the numbers are additive. Every new diagnosis goes on drug for the rest of their lives or until resistance. Unlike chemo, the revenue stream continues. Very powerful!
Does combo approval create back door mono approval?
Say you are fully suppressed but miserable on toxic pills. What’s to prevent you from creating a viral rebound (ie: stopping your pills for a bit) qualifying for combo, stopping the pills once you have access and whala, you are on mono?
brman
There is a table on page 60 of the 10-k which will get you the information. Just add 5 years from issue date to get expiration.
Good luck.
Mono CONTINUES to impress.
They should have added “and send chills through Gilead’s Board room” to Dr. Maddon’s quote.
And label expansion for mono by end of 19.
It’s gonna be fun!
Thanks Bee!
Any news on timing of BLA application?
Thank you. Doesn’t seem like a well thought negotiating strategy.
Was the announcement of a new Ph3 mono protocol as a result of FDA feedback or management assuming they will require another trial?
Anyone know?
Thanks
My guess:
Financing problem solved
Mono changed to pivotal
Followed by....
Mic drop.
Did anyone see the J&J ViiV study results for 2 drug combo? Atlas study released recently. It is a once a month injection.
Tox still an issue?
Maybe injection is not sub q?
Any thoughts?
Thanks! I missed Q&A.