Member Info for Tyke68

Trek
The tax credits alone are worth 25% rebate on clinical trials. That must be worth 10s of millions alone. Then as you stated there are all the grants possibly available. Based on the figures you quoted the other day I think/hope TB will go after $100m, a nice round figure for him to bow out on.
All just speculation but one thing is for sure this company is worth far more than the current mcap.

I hope everybody has a good weekend

Thanks

Don’t forget the 7 year exclusivity.

From what we have seen of Dr S and her team they appear very driven and accomplished and seem to be sure in what they are doing. Which should be great news for those suffering with GBM moving forward.

I would assume TB knows far more about the probability of the trials success than we do, so will he hold out for phase 2 results?

Could he possibly decide to sell the imaging side of the company to fund the trials? Could we apply for the grants but what timeframe will they take. Who knows what he will do. He will want to maximise his profit which in the long term should only be good for LTH. The only thing we know is the FDA want us to succeed.

Let’s sit back and see what happens over the next few months.

Thanks

If TB is going to do CLNs wouldn’t it have been better for him to do them when the sp was lower? He surely new the fda information was due so why not do them prior to that?
Just a thought
Thanks

Totally agree
If I was TB I would be looking for an exit strategy now, we don’t know what will happen with phase 2 or what the application to FDA for Zero will result in
All very exciting but the mcap doesn’t represent the value of this company at all in my opinion. Somebody must see this as an absolute bargain with so much potential.
Thanks

Dear RJH
After doing some digging after your post I found this article:

https://link.springer.com/article/10.1007/s43441-021-00364-y

It is very statistical article but what is says in the results section is very interesting in the valuation of drug companies including phase 1 orphan drug designation.
It quotes mean values well in excess of $100m.

I know this is wishful thinking but everything I read about orphan drug designation seems to imply a greater value of the company.

Fingers crossed

Thanks

RJH
I was using the numbers from Trek as an example but we can all dream.
Thanks

If TB was hoping that Bayer would be interested in the company, which others have alluded to before. Then I thought people might like a link to their current drug trials with timeframes.

https://www.bayer.com/sites/default/files/PH_RD_Pipeline_2023%2002_final.pdf

Not being an expert but just looking at what they are working on it would seem an ideal match. How much would TB want for the company is the (100) million dollar question?

Thanks

Trek looking at the numbers you quote. There is now way the company could afford that. However, if we were bought for say $100m a company could make a profit quite easily assuming the trial is successful. We seem to be progressing to phase two so for another company that has already reduced the risk and investment required. I think this is what TB is banking on.

With all the sales today a lot were multiples of 10000, so the questions I would have is who was buying them and why?

I believe the current mcap is nowhere near the valuation on the company at present with the GaM trial and its other products. Unlike a lot of tech companies it has products already on the market. All my opinions of course but we could be in for an exciting ride.

Thanks

I am sure sometime last year we were promised improved communication with shareholders. It is now March and has been over 100 days since the last proper update. I would not call this better communication, have we not made any progress in the last 100 days?
We need to know what direction the company is taking asap. Are we teaming up with a manufacturer, are we mining bitcoins, have we actually applied for a new patent yet, are we expecting any money from the court cases soon etc?
I know people with repeat how close we are but please let us know what sort of timeframe we are looking at.
I am still invested and want the company to succeed but we need to be told something quickly to help us keep the faith.
Thanks

Morning
I don’t think it was on the page yesterday when I checked. Also if I remember correctly they don’t publish names of those who have applied.
Thanks

I know it is a bit unclear hence my reluctance to share but it is in the public domain
The way I see it is the usa side of the company needs to publish the RNS but they are 5 hours behind us.

Fingers crossed

Hopefully we get a RNS confirming
Apologies if I have read this incorrectly but it definitely says designated

Hopefully this link works
It is dated yesterday

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=924822

Morning Howdlep
My reading of this is we have now been designated orphan drug status with all its benefit. Which is what we have been waiting for.

However, this does not mean we have been approved which can only be done after all the trials, data etc have been assessed. So that is a few years away.

Hopefully a RNS will appear today confirming this and hopefully the market reacts positively.

Apologies if I have read this wrong.

Thanks

I have just found this on the fda website

Generic Name: Gallium maltolate
Date Designated: 02/27/2023
Orphan Designation: Treatment of glioblastoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Imaging Biometrics, LLC
13416 Watertown Plank Road
Suite 260
Elm Grove, Wisconsin 53122
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

I am a bit confused if designated or not, one line says designated and one line says not Fda approved.

Does anybody understand what this means?
Thanks

If we do get the designation then we get
“What is the Orphan Drug Act?

The Orphan Drug Act is a law passed by Congress in 1983 that incentivizes the development of drugs to treat rare diseases.
Companies and other drug developers can request orphan drug designation and FDA will grant such designation if the drug meets specific criteria. Orphan designation qualifies sponsors for various incentives, including:

Tax credits for qualified clinical (in humans) testing

Waiver of the Prescription Drug User Fee (currently at almost $3 million for a new drug)

Potential 7 years of market exclusivity after approval

In addition, the Orphan Drug Act established the Orphan Product Grants Program to provide funding for developing products for rare diseases or conditions.”

So assuming all goes well (I appreciate it is a big if) with the trial and the product gets to market then just the fee waiver alone is worth nearly 50% of our current mcap

What I like is when Dr Schmainda had something peer reviewed then accessed previously it was given a perfect score. I would hope the same for this application.

We will hopefully know more within the next month.

Thanks

Pas
Sorry I never meant you re abuse. Apologies if I inadvertently applied that.
You are one of the ones I value for rational discussions. People don’t have to agree to respect each others points of view.
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22starship22
The longer this drifts along I think the more the abuse will become on this board. Rational discussions seem to be jumped upon if it isn’t positive. I hope people haven’t put all their eggs in one basket in case FG doesn’t deliver what we all hope for.
Thanks

So another week with no news
Yes a slight increase in the SP but obviously we need some solid information. I know we will have the same points posted by people again about what could happen but they are not facts. They just create arguments on this board when people disagree.

I guess the February options will be the first to be delayed. Maybe that will be the RNS we get first. We will all get excited when we see RNS in our emails etc and start ordering our news cars only to find out it is just an options update.

We need to hear some firm dates from FG soon and update on the court cases would be good.

Anyway I hope everybody has a good weekend

Thanks

Dear Kaneonaim,
Thanks for this. So by the middle of March we should hear back from the FDA and hopefully this is positive.
Thank you