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Winning Mabs should be able to increase volume substantially in the mid-term, without high capital costs or delays, for four reasons:
1)Switching a bioreactor from one mab to another almost never calls for new capital equipment. Contract manufacturers of mabs - like Samsung - couldn't exist if it did.
2)The special sauce (place where things can go wrong) is almost entirely in the scale-up (1L -> 4L -> 16L -> 64L in my day) portion of the grow. That's where unique tricks might be required, and the operator training is most demanding.
3) The big, expensive tanks for volume production operate with processes that are typically independent of mab, except for simple parameter changes. Low training (by FDA standards), low risk.
4)It's entirely possible to have Samsung replicate the scale-up labs without requiring retraining/certifying, making lots of slurry to send to multiple plants, where only the "big grow" tanks and related workers would need to be certified.
Of course we might need a leader to invoke the defense production act to claim the big tanks, but that's another story.
These points make sense at least as of 20 years ago, the last time I worked in a biotech that brewed it own mabs.
Agree - leronlimab is a diversified play. What will the vax companies have if they don't hit the jackpot on COVID? If some unheard of drug took COVID, CytoDyn would still likely have the most lucrative HIV franchise in that market, even before considering one or more of the many other indications.
On another board, a user said they exchanged emails w/ NP and he said he would not delay M/M results release for S/C interim release. I would hope a few days flexibility - e.g. take time for a meaningful write-up of M/M but release S/C the second headline results are available.
Per NP, 127 patients have now started the S/C trial (CD-12). 28 days until we have their last data - and at minimum a week after that for results. That's August 8th. NP says CD-10 will be released in July. Either all 127 patients don't finish CD-12 before unblinding or the two studies are not released together. Thoughts?
On the other hand, per Otto Yang, the ending of the sarilumab trial for non-efficacy and side effects may imply tocilizumab will reach the same fate, because they work similarly.
A Phase III trial for tociizumab changed status from "Recruiting" to "Active, not recruiting" on May 28th on clinicaltrials.gov, so June 25th would be their 28 day data. Tocilizumab is an IL6 blocker so broadly in our lane. Could well be what is to be announced.
Why more people in leron than lenzi phase III: 1) leron trial is 2:1 randomization - not as statistically efficient, (2) More patients ==> greater statistical resolution. If you want to make sure the trial detects a (underlying, long term) 50% reduction in deaths, you need fewer people than to be sure of detecting a 30% reduction. (3) Humanigen's endpoint is easier, so they are betting on big.
Leronlimab, THE Anti-ranti.
Great nickname, BronxBoy! The one and only anti-ranti! Nothing at all like it!
Probably have to keep the chemical name, but as a nickname, definitely. As in: Hey, Doc, please, give me the Anti-ranti ...
I guess I should be glad they picked Vyrologix over the others, especially Cytofeline.
Coronavirus autopsies paper, author on CNN - pervasive clotting is her main point. Platelet activation.
Sounds like RANTES to me. No other drug claiming to impact organ failure.
https://www.msn.com/en-us/health/medical/coronavirus-autopsies-a-story-of-38-brains-87-lungs-and-42-hearts/ar-BB16dALn?li=BBnb7Kz
Agree - this is a simple distribution agreement, not a more inclusive licensing agreement, which would typically include co-marketing and co-promotion. I expect the partner to be a pharmaceutical distributor (e.g. AmerisourceBergen), not a drug developer (e.g. Pfizer).
NP's wording would allow either.
NEJM weekly "table of contents" email: tons of articles on kids with kawasaki-ish COVID. Will leronlimab get EINDs for this group? It would be the ultimate proof of Patterson's theory of the disease. NEJM COVID articles are free to read. Don't know how to link this, though.
Yes, deferring the interim S/C analysis to include more patients could be great news. Another board stated NP had responded to an email by confirming he would ask the FDA for this. The jump in S/C enrollment to 120 was the biggest news today and presents a great opportunity.
Remember, statistical precision increases only with the square root of observations. So, compared to a 50 person study, 120 people is actually over halfway to the study's planned 390.
Put another way, if the width of the confidence interval for a 50 person study is "X," the width for a 120 person study is 65% of "X," and for a 390 person study is 35% of "X."
I can see the psychological argument for a 150 person study - 100 in the treatment arm - but past that it's diminishing returns. Based on run rates, that's before July 15th, implying last patient/last visit August 12th and reporting within two weeks thereafter.
In trade-off for about a six week delay, I think we not only get more certainty of statistically convincing results in this trial , but completion of a body of work on over 250 treated patients (75 EIND + 60 m/m trial + 100 s/c trial + 25 Mexico).
That body of work should make the FDA comfortable, and the American people confident in the FDA processes, in naming leronlimab as a standard of care for COVID-19.
Distribution deal is likely with a drug distributor, not a drug developer. Don't be disappointed if you see a name like AmerisourceBergen (they are the biggest) and not Roche, etc.
Some here appear be assuming the latter. NP wasn't perfectly clear - he stopped after the word "pharmaceutical."
It's an important note. If the question is stated "can leronlimab cut death rates by 50%," higher placebo death rates correspond to higher statistical power for a given number of patients.
120 patients enrolled in severe/critical? That's outstanding.
Remember, statistical power grows with the square root of observations. On that scale, going from 50 to 120 patients is more than half way to the 390 patient planned limit.
If we get excellent, but not "absolute-no-brainer" results in the S/C trial, the FDA may well respond with a second "interim analysis" based on about 125 patients.
CytoDyn's lawyers are vetting every word NP says. That's why it is recorded, IMO.
Jimmy - make it a movie! Citron is part of a Russian plan to derail America's response to the virus, utilizing the most cutthroat tools of capitalism (false testimony, media manipulation and naked shorting) to, well, cut our own throats.
Tocilizumab isn't a non-starter, just an unlikely finisher. We do want to reduce intubation and death, but, as Bobshmob had already noted, we won't finish the job until we can deal with the coaguopathies (sp?) and the awful disease in children.
So, on tomorrow's interview, some slightly different statements, in decreasing order of likelihood, that may be made about the COVID trials:
a) both trials have reached "last patient/last visit"
b) all data has been entered from LastP/LastV for both trials
c) Amarex has certified both data sets as complete
d) both certified datasets have been shared with the FDA
Some good outcomes on tocilizumab, but not randomized, as paragraph 2 of the Lancet paper notes: "a non-randomly selected subset of patients also received tocilizumab."
No question, the list of possible storm-treating drugs is narrowing to leronlimab (first with randomized trial results), tocilizumab and lenzilumab. And everyone understands we need storm-treating drugs.
Venture Cap - looking for source CytoDyn's lawyers were the cause of retraction. Lost in the flow. Can you help?
I missed the initial source stating it was CytoDyn's lawyers that forced Citron's retraction. How confident are we of that?
Simple response to any med investor friend: Citron used the same words ("SEC must halt") to drop INO from $14 to $6. It's now $27.
Assuming CytoDyn is working with an investment bank, you can bet they are taking a wholehearted (and skilled) part in any legal response CytoDyn makes.
Citron used same wording on INO on March 9th ("SEC must immediately halt this stock and investigate"):
https://www.bloomberg.com/news/articles/2020-03-09/citron-delivers-blow-to-inovio-s-surging-stock-amid-vaccine-hope
They put a $2 target on the stock. It is now at $27.
Isn't the US (and/or states) on the hook for stockpiles of HCQ as well? How much RDV will join them?
The Mexican cohort might be incorporated in US study. Or conversely, Mexico will evaluate data from a US study interim report augmented by data on their own population to support local approval.
Almost all of these studies are global. Given the protocol is parallel to the US version, it seems something the FDA might recognize. Mexico could certainly re-calculate a pooled p-value.
If stat significance is marginal on the 51-patient look-in, my guess is that the FDA would simply roll to a second look-in, perhaps at patient 125-150, or maybe a date certain - say July 20 to give Mexico a chance to contribute.
S/C enrollment is ongoing - 51 was "before June 1st." What's it up to now?
Wonderful resource - I'm sure there will be lots of suggestions for things to add. Thanks to the person who put it together (you Smiley? Jiro?)
Are they all Board members?
Do you think these are new hires? Is any of them the commercialization heavyweight?
Confirm Fidelity showing $6.70 / $6.79 as pre-market bid/ask
It would be a goodby performance on "Next Super Stock," if NP shows up, exiting stage right onto the NYSE.
Aha! Possible Priority Review notification Monday from FDA. Sixty days from BLA filing is actually Saturday, so could conceivably be tomorrow (if it comes).
Most imminent catalyst: Priority Review decision by Monday?
While we await the HIV 74-day letter (with its PDUFA date and list of issues) on July 10th, I note that, if the FDA has bad news (refuse to file) or good news (priority review), they are supposed to convey it on day 60.
That's this Saturday, so I guess we should give them until close of business Monday. Per the stated process, no answer is a negative answer.
I just sent this to Dr. Pourhassan:
I note the mild/moderate and severe/critical trials both collect the "change in 7-category ordinal scale* at day 14."
In the interest of statistical power, would the FDA consider** pooling patients from both trials in calculating the significance of this change? More precisely, an ANOVA (or its non-parametric cousin) fits this data structure perfectly.
* The scale has death as a 1 and out of hospital with no restrictions as a 7.
** As a post-hoc, secondary endpoint
Last-second trade dropped price to $4.99 from $5.03.
At 3:31, a persistently-refreshed 100k shares on ask at $4.99 held the price until the $1.3m share trade at 3:47 wiped it out.
There has to be a motivation here. Is it related in some way to the old "mainstream won't buy (or promote) shares under $5" adage? Other ideas?
100k shares on the ask at $4.99. That's a bigger volume number than we have seen.
Profit taking or making a statement that the stock won't be allowed to close at the $5 threshold today?
Another approach is to look at recent big pharma acquisitions. Gilead just spent $4.9b on a company called Forty Seven this March:
"The main draw for Gilead with the acquisition is Forty Seven's lead pipeline candidate magrolimab. In December 2019, Forty Seven announced encouraging results from a phase 1b clinical study evaluating the drug in combination with Vidaza in treating patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Magrolimab is also being studied as a potential treatment for diffuse large B-cell lymphoma (DLBCL)"
I don't know these diseases and markets but my naive reaction is that leronlimab is easily 5 times more valuable given the data, applications and clinical progress it has shown.
Let's add Roche as a potential buyer. Actemra didn't do squat in coronavirus. In arthritis, it did well, but is past its peak. Their other immune drug, Xolair, faces that soon. A lot of people around with immunological backgrounds looking for something new to work on. Huge cancer franchise if they believe TNBC results. Big U.S. manufacturing ability for MABs through their Genentech unit. And with a $306B market cap, they could pay up.