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Haywain,
How could the FDA hold Hemo’s solution when presently they have no definitive conclusion on this particular risk with Car-T ?
Don’t be so obtuse and patronizing to the many others here less informed!
Let’s see what the FDA March meeting concludes.
I presume you will offer the same as i , a full and public apology should you be wrong and new FDA requirements become apparent?
AIMO
Haywain,
We both know the FDA can only asses on the present understanding and of course presently, all is satisfactory.
To suggest confidence it can ONLY remain the case is disingenuous.
Big Pharma have expressed concern but you don’t’.
Who should investors believe?
AIMO
Ps.
I note your climb down on Auto v’s Allo’.
Haywain,
You state:
“The risk for the stated oncogenic potential of autologous CAR-t associated with DNA integration from the viral vector is as much of a risk in autologous CAR-T as it is in allogenic CAR-T but with allogenic presenting additional challenges that must be addressed due to the fact that the cell is not isolated from the patient”
…and yet the FDA position is :
“The FDA is specifically applying the perceived risk of T-cell malignancies to autologous CAR-Ts without touching on allogeneic, or “off-the-shelf” candidates, which also use the viral vectors”
I think I’ll stick with the FDA’s unbiased and present stance!
Let’s see how things progress with the FDA , March meetings and subsequent findings/recommendations.
As with my wager on funding with JFH , I’ll apply the same ( full and public apology), in the event there are no new FDA requirements arising for Hemo’ on this specific point.
Time will tell.
AIMO
Haywain,
Knowing you have a good understanding of the science, when questioned on the subject of Autologous, why are your views in contrast to the below article and present FDA thinking!?
You’ve chosen to ignore the risk which the FDA are considering and in stark contrast to the risks highlighted by the FDA and article referenced, actually claim advantage for the method Hemo’ utilise.
Why would you do that , what could possibly be your motivation!?
The lynch mob will no doubt bury this post very quickly, without any reasonable debate on what , in my opinion, should be a very important question for investors and one posed by the FDA themselves…not me !
The FDA March 15th meeting and subsequent findings may prove pivotal for potential Autologous Car-T treatments.
AIMO
https://www.fiercepharma.com/pharma/fdas-peter-marks-shares-more-info-car-t-secondary-cancer-probe-calls-new-drug-construct
“One key question that Marks and Verdun didn’t address in their article is why the FDA is specifically applying the perceived risk of T-cell malignancies to autologous CAR-Ts without touching on allogeneic, or “off-the-shelf” candidates, which also use the viral vectors”
Haywain,
Thank you for taking the time to respond.
We agree !
We both recognise “Durability“ is key and we both agree, multiple masking most likely has advantage where durability’s concerned.
We have differing views on availability of such solutions and the “relevance” to Hemogenyx.
Regarding availability and time scales.
I’m not sure you’re aware there are already competing solutions with Allogenic, multiple masking edits, for R/R AML , in trial !?
I’m sure your aware of the FDA March 15th meeting and why Allogenic may become medically more advantageous in addition to the existing cost/time benefits.
My point in all the above is;
Has the market considered the same and combined with the known difficulties within the AML drug trial arena, could that be the reasons for what some believe to be a languishing SP and mCap,…hence the “relevance”.
Let me add a little balance before the lynch
mob reach for their lanterns and pitch forks.
I do accept for a small Bio, Hemo’ have done an impressive job with their Car-T program to date.
I don’t discount the possibility that ultimately, Hemo’s solution could in fact prove more effective than those i reference above.
I recognise, multiple new treatments for R/R AML are needed and that there’s plenty of space in the market.
I’m not a Hemo’ hater as some might label me.
I’m a pragmatist and invest on probability and not possibility.
AIMO
Cryox,
I have my own supply of oxygen thanks.
It’s called free thinking & free speech.
It wont run out !
JFH,
You’re doing more harm than good to your reputation and the narrative you’re peddling by not answering. It’s not just me who realises!
Stinky Pete,
As promised, I’m getting out of Dodge.
I might return for that gunfight you mentioned.
HW,
“Durability” the holy grail !
I know you’re aware, durability’s one if not the biggest problem with these type of treatments .
In your opinion, would you think potential treatments with multiple “masking” gene edits have an inherent advantage where durability’s concerned?
Interested in an unbiased and honest answer from the most scientifically knowledgeable poster.
AIMO
JFH,
You’re avoidance of the question is very telling!
The “new” funding the company has stated required for P1 within the RNS , will it be dilutive or not !?
Yes or No.
AIMO
I’ll read response tomorrow, you’re driving me to drink!
HW,
I am sorry for your loss.
I doubt there’s a single poster here who’s not lost someone close to cancer.
I’m not going to divulge my experience, only to say it’s not overlooked me & my family.
I’m also sorry , my opinion on your post remains unchanged but i do apologize for any personal hurt it may cause.
JFH,
You’re confusing me!
You appear to be changing your stance in possible funding dilution.
In a sentence with less than you usual thousand words, could you please state clearly if you think P1 funding will be dilutive or not ?
A Yes or No will do fine.
For the record, HWire’s post was a little to sickly and riddled with double standards for my taste.
I’m very comfortable with my moral compass, thanks.
AIMO
Surfer73,
Good post !
My only observation, you’d have to be in “sone kind of parallel universe “ (JFH) , for P1 funding to be dilutive.
At last some balance without all the moral high ground BS clogging up the board.
AIMO
Pumpky,
I think JFH already believes there’s going to be a very painful dilutive funding.
I suspect all the flapping around , pointing fingers at anything and anyone other than the company and the AML arena risks, is simply laying the ground as a forward explanation of why, when it happen’s, the company had no choice because of those nasty shorter’s .
He’s getting a defence in early .
Of course he’ll flap around in response but time will tell.
If I’m wrong i will make a very public and humble apology.
I don’t expect to be doing so!
AIMO
JFH,
Now a question for you.
Q, Why would a company with a cure for “all known viruses and cancer “ (your words ) have any problems whatsoever in non diluting funding and as you repeatedly state, not have a much higher mCap?
There’s no logic to suit your argument.
This is getting tedious !
AIMO
JFH,
Your answer…Nothing !
Hemo’ are subject to the same risks and costs as others in the AML treatment arena. The mCap reflects the above and financial resources at hand .It is not disproportionate when properly considered.
AIMO
JFH,
Please stop banging on that the SP slide is due to anything other than what it really is !
And that is ,
…the risk and cost of clinical trials particularly for AML treatments.
The market recognises the above and just how difficult it could be to raise the necessary funding.
It’s very simple really.
AIMO
Stinky Pete,
I know you and the gang know where I am.
Maybe those who provided that information can send me another coded message to shut t f up or else.
I did keep a color copy before it was deleted, might come in handy one day !
They may have noticed , threatening me will not work.
GLA
AIMO
Mr I,
Just to preempt your conspiracy theory running wilder than normal,I’ll be going away again in about a week.
That’s regardless of the SP movement, it’s called living life, you should try it one day.
I suspect those in the dilution camp are expecting a much lower discount to SP than you state, time will tell.
AIMO
Mri,
“I would have thought anyone who believed this was a slam dunk from prevail or another pharma would be gobbling up these shares. “
Why are you confused when you’ve clearly answered your own question in the statement made earlier and copied above?
By definition, many do not believe it’s a slam dunk and are concerned about a large funding dilution.
Ps.
Your MO is so transparent . Complain a little about the company for credibility and then suggest only a fool wouldn’t buy right now.
You’ve been applying the same old for years, i’d suggest a change if you really want to influence 😉
AIMO