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Yeah that is true, but both Tocil and Saril are IL-6 inhibitors, and they were on the market before COVID-19.
CD brought those up in the last presentations, but I don't feel like they are at the same level as Lenz.
What about UK?
What are your odds on the approval?
Now that they have 60 day data and 'insufficient data', UK has more data before making a decision on the approval.
Last time you said FDA declined EUA because they are willing to wait for ACTIV-5, but if CD refiles EUA before ACTIV-5 full data, do you think FDA might decline it again?
Or would you think 60 day data might replace what FDA was wanting to see?
Some things that get on my nerves atm:
-CD refiles EUA without ACTIV-5 full data, if HGEN gets another denial from UK or FDA, the share price will dig all the way to the ground.
Although 60 day data shows a great benefit, if n was one of the issues, it still will be without the full data.
-Tapering and rise in the interest rate may occur in Nov, if so, the stock market might turn into a bloodbath.
-The current share price is $6.xx, this means we need to go up 3x to recover the share price before EUA. There was a massive volume in Sep, new bulls and shorts will sell and take their profit before the share price recovers to ~$18.
-Dale wasn't seen for a while, he didn't attend any of the conference calls after EUA.
What? No!
I even gave you the link about this.
FDA is being investigated by Feds because they approved Biogen's drug.
It got a bit suspicious after the approval, because Biogen's drug did not have a good safety data.
Ocugen has nothing to do with any investigations lol.
They were just declined for EUA and went on pursuing BLA instead.
Yeah people were being so immature on Twitter.
FDA, Jim Crammer, and others were being rebuked a lot by HGEN longs.
Too bad they are still being who they were before.
Did CD mention anything about type A meeting with FDA?
If CD changed his mind to refile EUA without the full ACTIV-5 data after having type A meeting, his bold decision is justified.
I hope you are right on this, but just being more objective or even skeptical here.
FDA looks at the benefits vs the risks, but if it was damn close, they would have asked HGEN for more sufficient data to show its benefits before sending out a decline letter.
FDA probably did asked for more data as they were having several meetings since the initial submission.
What comes across my mind at this point is that CD is trying to manage time frame by initiating first, then giving FDA more data from ACTIV-5 meanwhile EUA is undergoing.
I know EUA decision should be faster at the second request, but if it takes more than 60 days, it is likely that ACTIV-5 data comes out before the decision.
Mortality was one of four secondary endpoints. Let's say the 60 day data has the p-value of all of our primary and secondary points below 0.05. (and we did on 28 day data except for mortality)
I still don't believe mortality improvement alone would overturn the decision.
From the 28 day data, FDA probably saw a great improvement, especially for the group of patients with CRP<150, AGE<85.
FDA probably noted the improvement on SWOV, whereas mortality was better/similar to the placebo arm even p value was above 0.05.
If mortality was the problem, FDA and CD would've mentioned it.
It is more likely to have a small trial size is a bigger issue for the decline.
IMO, FDA already should have 150 from BET-B.
NIH decides to expand the trial in July, meaning DSMB came out before expansion.
If NIH had it in July, FDA would certainly have it before they made a decision.
I agree with you on UK approval. Maybe CD got too optimistic about approvals after having some meetings with UK.
UK wants lenzilumab for sure, and maybe CD thought FDA might overturn EUA decision because everyone around him is telling him EUA should've been there.
I believe in lenzilumab and the management, but I still doubt FDA will grant an EUA with this trial size.
If FDA suggested to refile EUA before ACTIV-5, then we might be gambling.
Last year, HGEN changed P3 criteria's multiple times, expanded trial size because FDA suggested them to do so.
We all believed the n was the reason for EUA decline, but if CD believes he could get EUA approval without adding more n's, he might be too optimistic after talking to some UK people.
I wonder what changed CD's mind.
Last week at Baird's CC, CD said HGEN is going to refile EUA with additional data from ACTIV-5.
After a week from then, CD changes his mind to refile EUA before ACTIV-5 data is collected.
The additional data will probably be 60-days from LIVE-AIR, and maybe interim data of ACTIV-5 with 150 patients (75% of 200 before NIH expanded the trial).
If FDA told CD that number of patients in the trial was the issue to justify its efficacy and safety, why would CD think extra data from LIVE-AIR and another 150 patients would get them EUA?
Did he just gain confidence after several UK meetings or what?
If FDA says n is the problem, n will still be a problem until he gets ACTIV-5 data.
I think CD was pretty upset how people overreacted with the word 'risk'.
He emphasized there were no safety issue in Baird call.
I hope HGEN gets UK approval, this will def mean something to US and EU.
An approval from any of the Big 3 will make a good impression on lenz.
If Lenz gets approved in Korea, the publication rights are owned by KPM Tech, a Korean company, meaning HGEN wont have much benefit on revenue if Lenz was sold in Korea.
You are right on the additional data coming from approved market usage.
Which also will probably support drug's efficacy and safety as well.
I know Lenz doesn't have any efficacy or safety issues, and I do agree with you that FDA want more quantity with similar quality they had on P3.
"risks outweighing benefits" is just a boilerplate FDA uses all the time.
They also add "send us additional data when available" at the bottom of the letter.
This is what Durrant copy and pasted word for word on the PR about EUA.
You probably know about this, HCQ letter said exactly the same thing except HCQ had cardiac issues.
BLA should be no problem if HGEN has a good ACTIV-5 data.
ACTIV-5 + LIVE-AIR + additional data from market usage will certainly grant them BLA without a problem.
Here's a news link for FDA getting probed for its corruption lol.
https://www.cnbc.com/2021/07/09/biogen-alzheimers-drug-fda-calls-for-federal-investigation-into-approval.html
Nope there are more Covid drugs that got rejected besides Ocgn.
For now, UK is our only option for any revenues up to this point.
An approval in Korea wont make a difference than what it is now.
It's more likely that FDA has given denial for HGEN's EUA as they became more strict on approvals after Biogen issues.
Federal investigation was put up after FDA approved Biogen's drug, even it had doubts about safety and efficacy.
If you believe FDA rejected EUA for HGEN in order to give them BLA, you are off track.
Ocgn was "recommended" by FDA to pursue for BLA instead of EUA, because they had no chance to get an EUA approval with the data they had at that time.
If you were to get an EUA approval, you need to outweigh benefits over risks, meaning you have to show and prove that your new med is better in efficacy and/or safety than SOC.
In Ocgn's case, Pfizer and Moderna +etc were already in the market.
In Hgen's case, we are targeting to replace or collaborate with Rem+Dex and Rem+Dex are either not good enough in the efficacy(REM) or the safety(DEX).
You, I, and every HGEN longs invested in HGEN bc they showed better efficacy and safety than SOC. Ocgn hasn't, but Hgen has.
Yeah I know FDA didn't apply those new terms to Ocgn and Nvax, but they somehow chose to go around.
It just doesn't seem right to compare Hgen to any other vax companies.
Same goes for AZ when people were asking for 'a company getting MHRA CMA with FDA EUA denial'.
Plus, as I said before, refiling an EUA is a better option for HGEN.
Because it is a refiling process, the overall timeline should be shorter and they still can file BLA with P3 and A5 data.
I don't really see a point of not refiling a new EUA.
You shouldn't compare Hgen to Ocgn.
FDA earlier said they are not accepting additional vax for EUA, which kinda overwhelmed vax companies.
Nvax and Ocgn were up next, then they delayed applying for EUA or decided to go for BLA.
For Hgen, CD would probably go for EUA first, because with or without CMA approval, they need their revenue to start flowing.
BLA would take months longer which isn't really favoring Hgen.
So they would refile EUA first, then go with BLA right after.
I'm still holding my HGEN shares and I love the company as much as you do, but I highly doubt that FDA was asking for more data for a BLA.
The data should be fine. They have done multiple DSMB's at P3 and Activ-5.
So the integrity should not be a problem, otherwise the trial in both P3 and Activ-5 wouldn't been expanded in first place.
I guess they just want more data from US sites.
GM-CSF is something new, and if we were to ignore the data from Brazil sites, Lenz needs more data to prove itself for more efficacy and safety.
You are kinda right on the track.
If they were approved, the production would've speed up, eventually ending up producing more than 100,000 doses for sure.
As they are rejected, they are more focused on managing budget, consequently leading to decrease in production.
This is something CD said in the recent PR as well. He was emphasizing about the money will be carefully managed, so the cash flow in Q4 wont have any problems.
The stockpiled doses will last about 3~5 yrs, but they can't keep producing and stockpiling while the approval isn't there.
If, and hopefully, MHRA gives us CMA soon enough, HGEN will probably continue producing and eventually have way more than 100,000 doses in 12 mths.
It still takes months to make a vial though, so CMA is the fastest and the best option to keep HGEN going.
You got it right on the math part, but HGEN is not capable of producing that much of vials.
It takes more than 6 mnths to completely produce Lenz.
Earlier this year they said the initial goal was to produce 100,000 treatments over next 12 mnths.
I hope you are right, but FDA decision just got longer after this spring.
NRXP is also waiting on their approval for 100+ days, but the odds seem pretty bad imo.
Rem's case wont really apply to Lenz, the circumstances are different than what it was before.
I just hope you are right on everything like you were before when EUA was denied.
CMA approval seems more of a reasonable catalyst than EUA in NOV.
EUA delay pushed over the plan to next year, hopefully MHRA sees the bright side on Lenz and grant CMA soon enough.
Dec/Jan still seems a bit early for EUA approval.
Hgen got a denial, not a pending for additional data.
I agree with you it will come around faster than the expectations if the trial finishes early, then NIH will note FDA for EUA.
If the trial fills up to 400 (with CRP+age restrictions) or 550 total, I would assume it ends around NOV/DEC at earliest.
Then the data gathering will take another month or two. Filing a new EUA would take another month.
As they are going through same process, it would speed up more than the first time, which I'm expecting 1-2 months advantage.
This is how I came up with my best guess of MAR/APR.
The most realistic estimate will be CMA first, then EUA comes after ACTIV-5 along with EU submission. Which would be Nov/DEC, MAR, APR, consequently.
Is there a reason why you are predicting EUA to come around Nov?
As far as I know, ACTIV-5 enrollment completion will come around NOV-DEC. Then HGEN will file a new EUA after gathering data from the enrollment.
My best guess for EUA was around MAR-APR 2022.
Did you mean CMA from MHRA in NOV?
Or are you expecting DSMB from NIH for EUA approval?
I just saw this vid on youtube.
He says he was long on HGEN then sold all of his shares after seeing some "red flags" lol.
What do you guys think about this?
It should be $10000 per patient. They were kinda going through this earlier in this year. They saw benefit of Lenzilumab saving some money for patients from hospitalizing fees by shortening the days to be hospitalized.
So it is $10k for 1800ml of Lenz
The treatment consists of three doses.
600 ml for each, total of 1800 ml
They are provided through IV, 3 times a day with 8 hours interval.
You can see this everywhere in presentations posted on HGEN website.
So true. The current treatment is SOC, combination of Rem + Dex.
SOC at this moment is not really effective, it makes moderate process to critical or somewhere in between.
From those CPR>150 data and the fact that NIH said there is insufficient evidence in GM-CSF inhibitors treating COVID-19, FDA might have seen this as a potential risk.
Would you consider FDA denial might come from CRP<150?
The patients enrolled in both P3 and ACTIV-5 include patients with CRP>150.
But the data collected were only counting patients with CRP<150.
Do you think there's a chance FDA might have seen this as 'less benefit'?
Thanks cowtown jay for a welcoming kind reply.
I see where you are going with this.
Do you think Humanigen is submitting their Activ-5 interim data to UK as well?
I tried to find any companies that were rejected after the rolling review by MHRA, but I couldn't find one.
I appreciate your post. Thanks for sharinig.
Can you tell me who you were with on the phone?
From Scrip article, it says they had 300 patients enrolled out of 500.
So the actual number is 200-250 instead of 300?
If they are stopping with manufacturing, are they assuming they have little chance to get CMA approval from UK?
Good point, but something seems a little bit off.
If Humanigen was granted EUA, NIH would still proceed with ACTIV-5.
Durrant initially planned to get EUA and CMA, distribute lenzilumab in US and UK, then go for BLA with data from ACTIV-5.
Although NIH and FDA are working close together, they still can have opposite ideas. Maybe NIH thought lenzilumab was worth doing more research, while FDA thought they need more data to see if lenzilumab was efficient enough to be on the market.
From the data I saw on P3, the data from ACTIV-5 should be as good as what it was on P3. And yes, I also believe HGEN will def get a granted EUA.
Don't get me wrong, I'm long HGEN, but just making some assumptions.
What if NIH is thinking the same thing as FDA?
After getting data from 200 patients, they weren't sure if the benefit outweigh the risks.
So they wanted to take a deeper look and increased more enrollment.
They wanted to give it a shot because most of their ACTIV trials has failed or terminated.
Is there a possibility that this assumption may be true?