Member Info for stu485

JFH95%,

“ so where did your confidence come? Are you in communication with Dr Sandler?”

If i were you I’d take that post down as quick as you can.

AIMO

One2One,

Nail & Head !

What you’ve outlined is my greatest concern and one I’ll post more details about tomorrow.

AIMO

JFH 95%,

I’d be very careful with posts like that!

I don’t care what you say or think about me but suggesting VS has been involved in insider trading on a public forum might be considered libelous!

The facts pointing to a likely FDA hold were there for all to see. The company even tried to make you aware of the risk but you’re to rapped up in your own overblown ego to realize.

AIMO

HT, Mr I 95%,

I’d like to say I’m surprise by your inability to grasp the facts and stats…but I’m not !

You constantly show yourselves up and fail to understand very simple science and statistics.

Keep trying to discredit me even though i keep proving you wrong and will continue to do so.

Remember, if it wasn’t for HT’s encouragement I would no longer be a shareholder and poster.

Thanks HT

AIMO

Q, DID HEMOGENYX TELEGRAPH THE RISK OF FDA CLINICAL HOLD ?

A, My opinion, Yes they did !

Hemogenyx clearly communicated the risk of an FDA clinical hold within their RNS communications.

It’s been suggested that i must be a Hemo’ insider to have known a Clinical Hold was coming and sold the 50% of my holdings when i did.

Of course i’m not ! I simply acted on the information Hemogenyx themselves had provided within RNS statements combined with a little research of my own on the subject of, Oncology IND’s.

So my research, one item attached, was very clear that the type of IND submission and the specifics of the company making it have a major bearing on the likelihood of FDA clearance. This information alone, enough to realise the high risk of a Clinical Hold.

Just reflect on what the 95% ramp gang said !

Now to the Hemogenyx information.

“We have been particularly concerned to cover all aspects in preparing the IND documentation so as to MINIMISE any possible delays and questions that may arise from its review by the US Food and Drug Administration ("FDA"). “

I’ve highlighted the key word within the RNS.

Some may feel misled by the wording and believe it reinforced their conclusion that there was no chance of an FDA clinical hold. Unfortunately for them and legally speaking,that’s not what it says.

I have a career of writing and interpreting complex technical documents where the authors (sometimes me) push to the boundaries of legality, a notion they wish to promote. To stay within those boundaries they will use key words that can change the legal understanding of a statement. I believe “Minimise” the key word within this statement.

Hemogenyx communicated that they anticipated the possibility of some FDA questions and delays in the fact they advised they’d worked to minimise them.

So Hemogenyx did telegraph to all an FDA Clinical Hold was a very clear possibility. Combined with other easily available third party information on IND submissions it was always a high probability.

Hemogenyx are blameless for the frenzied belief on this platform that IND clearance was a formality . The blame sits squarely with the 95% Ramp gang and their postings.

“Will the FDA clinical hold be lifted quickly and is it even the main concern for Hemogenyx Car-T advancement? “

More to follow.

AIMO

https://pubmed.ncbi.nlm.nih.gov/31678263/

HT,

Think you’ll find I’ve defend the company but attacked the ramp gang.

Don’t worry there’s another example coming, you’re the star of the show!

After which I’ll only be looking forward and trying to answer the question we all want to know,

What are the FDA concerns and what’s the timeframe to resolve, if they can?

You got anything of actual substance to contribute on that subject … no thought not !

AIMO

L712,

The majority of my posts do not criticize the company, in fact some of my posts defend their position and communications, where many so called LTH’s attack.

For example, when the 95% ramp gang were constantly posting IND submission would be immediately following PQ3 , i posted just how complex an IND submission is, that it was likely to take a considerable period of time post PQ3 and that Hemogenyx would not appreciate shareholders suggesting otherwise as it creates unwarranted time pressures within market expectations.

As I normally do, i used independent references to substantiate my argument.

Of course the 95% ramp gang, tried to discredit and drown my postings as they always will. Guess who was correct!

I will give another example shortly in a post titled ;

“DID HEMOGENYX TELEGRAM THE RISK OF FDA CLINICAL HOLD”

So to be very clear, I do not unnecessarily criticise the company. However, I do believe some criticism is now warranted and will come to that latter. Just to briefly say,Tranche 1 stock options should now change to the same qualifying criteria as Tranche 2 and the same price.

This forum is not a Hemogenyx fan club neither is it’s purpose to deceivingly attract unknowing new investors.

My understanding is it’s for sharing information and insight on both positive and negative aspects that may help determine the trajectory of the company’s fortunes and SP.

AIMO

HT,

Classic HT !

The balls in the back of the net while your still trying to trip up a player.

See you Monday as a continuing, disillusioned share holder along with all the others.

AIMO

HT,

You’re about to be the second most unpopular chap on this board !

Only due to your taunts, i’ll hold !

I can only continue to post with such conviction and without the threat of litigation, as a shareholder.

Unlike many of the unfortunate individuals tempted by this stock, though not wealthy i can afford the further loss i expect to transpire.

So I’ll stay and I’m sure we’ll be on opposing sides of all the argument and discussion to come until such time i decide to move on.

To use a football analogy, you seem to believe playing the man and not the ball is beneficial.

If you are the significant share holder you claim to be, start looking at the bigger picture, don’t obsess with me and perhaps your financial situation might improve.

GL

AIMO

JFH/Mr I,95%,

Can you not understand that constantly making assertions that conflict with the actual facts ,FDA IND process for example, is not an opposing view, it’s either stupidity or deceitful manipulation .

Neither have a place on this platform…well maybe stupidity hey Mr 95% ?

AIMO

HT,

Nope, i said i will be selling my remaining holding as soon as i can and that until shot of the stock, I’ll continue to correct any blatant BS the ramp gang creates.

AIMO

JFH/Mr I (95%),

Seems your disciples are leaving the fold !

The problem is , they’ve started to see through your deceitful and fact avoiding postings.

Here’s the first question;

What was the appropriate percentage chance for the specific IND clearing without a hold?

I explained, given the type of application it would be wrong to simply consider the average of ALL types of IND’s and such an inappropriate and simplistic assumption would result in an incorrect answer.

When that incorrect answer became apparent, the FDA hold, which you guaranteed would not happen, you Mr 95% suggested it’s just bad luck Hemo’ were in the 5% of failure’s !

Even your most fanatical disciples could see through that one.

Another question,

Reasons for the FDA Clincal Hold?

You’ve claimed all sorts of trivial reasoning in your various guises, NONE of which exist within the FDA listing of possible reasons (attached below).

You’ve also stated (through your Mr I puppet, Hemo’ don’t know the reason for the FDA hold, when in actual fact they do ! Part of the process requires the FDA to outline their concerns to Hemo’ and try to resolve PRIOR to issuing a Clinical Hold…it wasn’t resolved !!!

Maybe your starting to realize why your losing the audience!?

And now, as I predicted would happen, there’s a scramble to big up CBR the “ Microscoft of Pharmaceutical “ , whilst at the same time suggesting the FDA hold is but a bump in road.

Well myself and it seems many others now believe it’s actually the END OF THE ROAD for Hemo ‘ Car-t and the remaining stuff is not worthy of our investment.

AIMO

JFH/( Mr I) aka 95% ,

Below the ONLY reason the FDA can place the particular Clinical Hold, in accordance with the FDA policy.

So rather than suggest , they put the wrong type of stamp on the submission envelope or other BS to lure in more unsuspecting investors in the hope this is just a simple formality, choose from the FDA list below and then explain why, it’s no big deal !

I know you’ll completely avoid the facts and question posed as there’s no reasonable argument that fits.

At least others will get the chance to read, consider and act from a position of truth & knowledge.

Now all jump in and try hide this post with waffle.

I’ll repost Monday.

“Grounds for imposition of clinical hold:

The grounds for imposition of clinical hold for a proposed or ongoing Phase 1 investigation include the following:

Human subjects are or would be exposed to an unreasonable and significant risk of illness or injury; or

The clinical investigators named in the IND are not qualified by reason of their scientific training and experience to conduct the investigation described in the IND; or

The investigator brochure is misleading, erroneous, or materially incomplete; or

The IND application does not contain sufficient information needed to assess the risks to subjects of the proposed studies; or

The IND application is for the study of an investigational drug intended to treat a life-threatening disease or condition that affects both genders, and men or women with reproductive potential who have the disease or condition being studied are excluded from eligibility because of a risk of reproductive toxicity (i.e., affecting reproductive organs) or developmental toxicity (i.e., affecting potential offspring).

However, this criterion does not apply to circumstances when: (1) proposed studies are pertinent only to one gender, (2) proposed studies are conducted in subjects who do not have the disease or condition for which the drug is being studied (e.g., some studies in healthy volunteers), (3) another study that does not exclude members of the other gender with reproductive potential is being conducted concurrently, has been conducted, or will take place with the same investigational product within a reasonable time agreed upon by FDA. “

AIMO

Ps until i get shot of my remaining holding, I’ll correct any and all lies .

I said I’d get off the tragic Hemo’ bus at the next stop.

That being the outcome of the FDA IND submission.

We’ll i am.

Like Wyn’ I’m now more comfortable in taking the hit on my remaining 50% holding than continuing with this farce.

There’s much more to say and explain with fact and independent third part referencing on MCAP comparison, chance of ever gaining FDA clearance, and the true value of CBR etc but… the ramp gang have done their job in exhausting me, so good bye for good.

HH,

Come back ! They need you more than ever but please show a little more compassion for the uninitiated potential new investors.

Final note.

Do me favour and remind Mr 95% how spineless he is and magnificently inept at understanding the wording within RNS communications.

AIMO

GLA

Ps watch out for Mr I , gives the impression of an idiot but actually a ramping tool.

…the same K**b who recognised distraction in posts prior to the disastrous RNS of today and the same K**b who’s rumbled Mr I as a very cleverly orchestrated rampers mouth piece . ( that did take me a while !)

AIMO

N01,

Yep that’s me a K**b .

The same K**b that was completely wrong on this IND outcome.

See how your insults a bit misguided?

AIMO

Mr 95% I,

Let me substantiate, just in case your fingers are moving .

“It’s still the same gamble as before”

So, let’s consider that statement.

Hemogenyx lead product which they state is their focus and been working to towards getting FDA clearance for years, has just failed to gain that clearance and now on full clinical hold .

We, like Hemo’ themselves, have no idea when it may subsequently clear or if indeed it may never clear.

So let’s now consider the above facts…is it really the same gamble ?

Come on JFHI, i know they’ve not given you much to work with but very poor effort, must try again.

Unfortunately i know you will.

AIMO

Mr 95% I,

I think you need to go have a sit down before you post again.

You’re really making yourself look like a fool and i know your not.

AIMO

Mr 95% I ,

“Silly admin error”!

Can you not read ?

FDA will in the first instance call the company to discuss and try and resolve whatever the issue may be.

Should that fail yet it’s not a massive problem, they’ll issue a Partial Hold on tbe soecific aspect requiring further details/clarification.

So in fact, and according to the FDA policy and Hemogenyx RNS , this is a FULL Clinical Hold , so don’t be so stupid to suggest it’s an admin’ error Mr95% I .

AIMO

CD,

I think you meant… Mr95% &Mr I are one and the same!

AIMO