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The best path forward for HGEN would be finding a disease caused by a genetic anomaly that overexpressed GM-CSF. I do not know if such a thing exists. There are genetic variations that cripple GM-CSF and cause disease.
"The trial did not achieve statistical significance on the primary endpoint"
No surprise to some of us.
Drugdoctor pumped and dumped this POS stock and now comes back to gloat at the horrible price. Pretty damn scummy.
Still waiting?
It can impact budgetary concerns if it gets approval.
HGEN isn't in a death spiral there are probably niche markets for it. CYDY isn't in a death spiral either it's just a short term waiting game.
CYDY now over 4x the market cap of HGEN.
He must be in a desperate position to be pushing RLFTF. He even includes RLF-100's "anti-viral" properties. I call BS on that when Javit's first made that claim.
Even I call bullshit on that video. GM-CSF shouldn't be used in the early treatment stages of Covid but that's not the market HGEN is going for.
HGEN is definitely a no go for any short term revenue relief from the GVHD trial. It hasn't started yet and they will be recruiting patients over the course of 3 years.
Taking into account the actual $74 million on hand and the $25 million loan owed even if you were to use the previous cash burn rate of $7.3 million HGEN will burn through the cash in under 7 months. If no EUA will HGEN have the GVHD trial finished and approved by then?
Current cash burn around $22 million a month. If no EUA your cash runs out in less than 6 months.
Not much in the ole clinical trial pipeline and the only other in phase 2/3 is GVHD which is low revenue. There's a reason why Cytodyn abandoned it in favor of more lucrative diseases. Although I'm sure they'll get back to it when the revenue piles up. Everything listed in that pipeline leronlimab can cover and do it better.
What do you think HGEN share price will be after the Activ-5 trial is released? I would think $2.50 at best.
At this point why would they bother doing a reverse merger. This is played out. Give it a year or two they'll let it go fallow and then engineer another reverse merger scam.
Unfortunately HGEN is a lowrider. Once you hit a speed bump there goes the whole undercarriage.
I see where they mention CRP < 150. Since it's not an inclusion/exclusion criteria all ordinal scale 7 patients are thrown out of primary endpoint consideration which makes the patient population smaller. Then consider the number at ordinal scale 5 and especially ordinal scale 6 that are over CRP > 150 that might leave a small enough population that there's no way it hits a statistically significant p value.
Bur as the NIH says -
Nowhere in the Activ-5 trial does it mention CRP < 150 in the inclusion/exclusion criteria. In fact inclusion of ordinal scale 6 and 7 would mean many would be CRP > 150.
I think they were turned down because of lack of benefit. Their p value was p=0.0365 but they had changed endpoints. It could be that the FDA thought the p value was not valid.
The FDA says they will look at additional data and HGEN is pinning their hopes on the Activ5 trial. HGEN's trial was for severe/critical patients, Activ5 is for moderate to critical. HGEN's primary endpoint is Ventilator-free Survival, Activ5's primary endpoint is Time to ventilation or death in subjects with a baseline score of 5 or 6. The inclusion of moderate would not be beneficial to HGEN at all. The only potential saving grace is that the control arm consists of remdesivir with placebo. That they use remdesivir only in patients above mild ensuring a death sentence for many is criminal.
No EUA, who could have guessed.
One should be you, I apologize if I failed to include you in that group.
What effect does a drug have if it isn't used?
Just pointing out to a troll his bad investment.
I guess the admins don't like it when you call POS by their correct name.