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Agree. Small bone to throw weary longs since did not meet estimated timeline for data release.
I made good money on CYDY and got out at a nice time. Put those monies into HGEN with some additional funding and did well buying and selling a few times during the run up.
Had a nice position and then just sat and waited for the EAU decision. Got slammed of course with the rejection and backslide thereafter. But I have continued to sit and wait for it to take off. I believe in the drug and management.
I keep my wife informed when she asks how we are doing. It was difficult to advise her we have a considerable net loss on HGEN. I told her more than once that I expected positive news very soon in late first quarter/early second quarter. That time has now passed.
So further delays are frustrating and I do not want her to think I'm stringing her along on a dying duck. But I'm still here.
Make it so. You convinced me but I'm fully invested.
Wish I had bought in at this price point. But will have very little regret if the upcoming data supports LENZ's effectiveness and vast possibilities.
Would like to know about the FDA meeting. Would appreciate just hearing from mgt when it took place. Hope you are right about hearing from MHRA any time.
Tired of your endless whining Yoo. You could have gotten out of the stock but didn't. That's all on you, Yoo.
Looks like you, Yoo are a short working to drive the SP down.
Stock Price is being beaten down as if the Brits, Europe and FDA want nothing to do with us. Very discouraging end to the year. Had really high hopes for this drug and its management.
This is a good post CJ! Like the attitude.
Excellent News and we can use it!
This is great news about FDA reconsideration and should be dominating our discussion today.
I agree with your concerns about CJ's repeated posts about CYDY price parity. I have expressed my dislike for these type of posts on two previous occasions.
It is something that only CJ seems to see and I think only he seems to see as important.
I value CJ's posts on other matters.
Too many facts for others to handle. Only hope for this company after so many failures is a change of management.
Come on Nader, not fooling anybody here with smarts.
CYDY has not accomplished anything of value.
I've reviewed FDA documents and can not find anything that mentions decline vs denial as separate classifications. Decline is the the word that is used. If you have something that discusses denial vs decline, it would be helpful if you posted it.
Here's what I'm basing my thoughts on https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities
FDA may decline to review or issue an EUA based on any number of factors. For example, the candidate product may fail to meet the necessary criteria identified in section 564 and discussed in section III.B.1 of this guidance, or it may fail to meet any one of the factors given the circumstances of the emergency or threat of emergency (see section III.D.4.a of this guidance for a discussion of factors FDA will consider in reviewing requests for prioritization of EUA requests). Under such circumstances, the relevant product Center will notify the sponsor that the EUA review cannot be prioritized or FDA declines to issue an EUA for the candidate product.
I think that the statement about potential risk is FDA boiler plate language used in its conclusion for declining the EUA request.
FDA declines EUA. Its on the company website.
Twits is nothing but bashers and shorts at the moment.
Hard to wait when you see the need and the ability to help.
If you think its time to file a complaint, than do so. Exercise your right as a citizen.
I do not see it that way. I think its premature and speculative.
I want HGEN to succeed as much as you do.
I think it is up to the company/mgt to decide if they need to seek federal oversight regardless of our frustration as we wait.
Some shareholders raising cain at this moment IMO could possibly embarrass mgt, other shareholders and the company as a whole.
We can only speculate as to what is happening. Our drug is not approved for any other purpose and it may take longer for the review than we would like.
I'm not willing to go to the point at this timeto think dark forces are conspiring against us.
Though I reserve the right to change my mind.
Of course, it played a large part in the FDA letter and may have influenced the DOJ and SEC subpoenas. As Engineering Simple said we have no idea what is going on at the FDA related to HGEN.
HGEN mgt will have some clues based on data requested and communications with FDA.
But what we know is that FDA accepted the application which is a good sign.
We could get a decision tomorrow or this week but maybe not.
As honest as a three dollar bill.
Thanks for the pep talk we need encouragement as we wait. Too much time on our hands.
I put him on ignore many moons ago. Some people must be bored with waiting.
It could be said it was an easy no for the FDA because it was so underpopulated. But why accept the application to begin with?
As you may have hinted it may be due to the pressure to find a treatment for more severe hospitalized patients. Which could mean the FDA is clearing the field before announcing that they have found a treatment that deserves an EUA (Lenz).
With RIGL data being submitted in late May also you would surmise that we will be hearing from the FDA very shortly.
As said with such low trial numbers its a wonder it was allowed to apply.
I thank you for repeating this information.
I'm looking for an explanation for the selling that doesn't conflict with a positive outlook for the company. Hopefully, we are seeing this right.
The selling was first mentioned as a pre-established arrangement that was outside of Dale's control but it appears to be more than that.
Need to vent.
Great presentation just need to check the next timeline and off we go.
Another day down but closer to the end. Just need to get through this week.
This article states marketing authorization granted by UK 7/12/21
Posted on Twits
bioworld.com/articles/50920...
Thats the whole thing all the delays and missteps by the company have allowed competitors to catch up or surpass CYDY for HIV.
BTW Did you catch the 8-K filing that the company buried after hours this Friday. Arbitrator ruled they owe @ 8 million dollars for their misdeeds and 3 million more shares of stock.
There are no catalysts or revenues coming to this company for a long time.
They screw up everything they do.
The only hope this company has is if there is a change of mgt.
Well first there was talk about how FDA was working with HGEN to provide guidance for trial design and how the FDA by accepting the EUA application was indicating their likely approval of Lenz. Basically, that the FDA and the government was in in our corner.
Now the the talk has regressed so that now the FDA needs to be intimidated into granting an EUA and that they are against us because we are a small biotech.
I think we have too much time on our hands. We have basically two weeks more to wait. A decision could come any time. I think FDA and UK decisions will come together.
Gotcha. Thanks
Its nearly 6 weeks since HGEN applied.
It must have been so painful for you to see this. My sympathy to you and your family.
Over half way to 60 days from date of EUA application submission.
Astounding that price is where its at. FDA decision could come very soon.
The waiting is the hardest part.
I have substantially increased my position three times after the initial buy. As we move closer to EUA and revenues I have increased my shares as my confidence grew and the risk decreased.
If lenz hits as we believe, this will be known, as was said, as the days of printing money.
I just updated. Thanks
Bought another nice chunk at open after having to wait for additional funds to become available. Looking for a nice day and week after the European news.
Thanks Gustyhu. Missed the call and appreciate you providing details. I'm waiting for some money to be shifted so I can again increase my position.
Very good post. Thank you.
What should have been a catalyst segues into a move designed to doubt your holding and acquire shares on the cheap.
Opposite effect on me, ticked me off to the point I'm going to move some money around and buy more shares. But its going to take a few weeks to get it done.
This was posted on my trading account.
On May 24, 2021 Refinitiv/Verus downgraded HUMANIGEN ORD SHS from HOLD to SELL.
Surprised by the timing of this. I can understand a hold to a degree but not a sell.
Thanks. Impressive presentation. Hope we can check off another box by weeks end.