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Whilst everyone is entitled to their opinions ( ridiculous or not ) one cannot conceive that this RNS implies a GO for the P3 trial , imo
The wording of the RNS is fairly explicit..

Notaflipper,

I agree with most of what you have written …we just don’t have the same interpretation..
We will just have to await the next RNS to gain more insight into what the FDA has requested ..

PS one has to read the RNS 5 times as these are usually ´well worded ´

Djm1,

Whilst this is a disappointment for most here , my take is that this is largely anticipated by Avion and IMM and whilst it may take longer , it has much better prospects for the future so everyone to their own trades but imo well worth a punt …
Frits the difference with a punt and an investment ?
Let you figure that out :-)

Notaflipper,

I cannot agree with that …

The FDA response was detailed and included significant guidance on next steps for the clinical programme. This included advice on the dosing regime.

Dosing regime is not done in a P3 trial , imo

Whilst we may be doing a bit of a U turn , this is a positive thing for the future !

And imo , largely anticipated by Avion and IMM

A bit more downbeat than the imagined one , but essentially the same …

The FDA response was detailed and included significant guidance on next steps for the clinical programme. This included advice on the dosing regime. In addition, the FDA also provided further significant guidance on the study protocol that can be amended to improve the regulatory outcome.



The Company is currently reviewing the written response with Avion and will make a further notification in due course, imo

The FDA response was detailed and included significant guidance on next steps for the clinical programme. This included advice on the dosing regime. In addition, the FDA also provided further significant guidance on the study protocol that can be amended to improve the regulatory outcome.



The Company is currently reviewing the written response with Avion and will make a further notification in due course.

I can imagine the possible press release

´ Immupharma are delighted to annonce that our partner Avion has informed us that they have agreed a regulatory way forward for Lupuzor with the FDA :-)
……..’

´ After our successful PK trial , the FDA has requested that we do an optimized dosing study before commencing the P3 trial and we have agreed with our partner to immediately commence this study whilst preparing the full P3 trial ‘ …..??

I can imagine the possible press release

´ Immupharma are delighted to annonce that our partner Avion has informed us that they have agreed a regulatory way forward for Lupuzor with the FDA :-)
……..’

LLL,
It’s not popular to say things that go against the Rocket , pump&dump crowd , but whatever, it’s okay to look at the other side of the coin , is my view :-)

LLL,

My take on this is that the FDA might refuse the P3 trial , if equivalency is not demonstrated because of the changes made to Lupuzor .
I imagine that the changes made were due to Avion wanting a more ´sellable product ´ with patents extended and a lower cost of manufacturing, which makes a lot of commercial sense , imo
If the FDA refuse to allow the p3 trial , they would certainly allow a P2 trial ,imo
Now Avion and IMM have regulatory experience and therefore they must have weighed up the risk/ reward of doing the changes and taking this road with Lupuzor so even if they have to do a U turn , they will be better positioned to bring it to the market even though it might take longer to get there .
The official communication from IMM is imo very optimistic and my opinions should therefore be taken with a pinch of salt and only time will tell ..

Djm1,

I am just worried about my neurons, and wondering if Frits is right for once …

I cannot understand why Tim would imply a rubber stamp situation with the FDA , after altering the formulation/ CMC of Lupuzor ( which nobody talks about but me apparently)
I wonder why ?

The only ones making money so far are the L club but things may change if a positive RNS .
I presume that L1 will try to flog their 3 million shares first and then we should see a new conversion RNS , imo , but I could be wrong …

Frits ,

When you can spell my name correctly and be civil , you might have some chance of reply’s…
But
That would be like asking for a miracle , imo

In the bottom drawer , whilst awaiting News ..
GC will be filling up more in the meantime, imo

Whilst no one can predict the market reaction to news , one should consider the reaction to L1 and Lind options , imo

For instance on Monday , we have these 3 million coming

An application will be made for the New Ordinary Shares to be admitted to trading on the AIM market ("Admission") of the London Stock Exchange. It is anticipated that Admission will occur on or around Monday 12 September 2022.

A late Friday RNS is usually bad news in my experience..It gives the week end to DIGEST the news
But everyone to their own opinions

Everyone to their own trades and beliefs . Once one has done their own research, and has properly looked at the pros and cons , and come to enlightened decision , one can then implement the strategy that suits themselves .

Eyes to the sky but keep the feet on the ground .

Frits ,

It’s not the suspenders you should take off , it’s your blinkers :-)

But what the heck….

If one looks at the graph and volumes traded , one would be inclined to agree on the options shares being sold to the market , imo

Doing a back of the envelope calculation, one could imagine that they now have a net position of 3 million shares ( at a net capital investment of £105k )

BWTFDIK