Immupharma Share Discussion Threads

[top tips] 04/12/2017 09:44

This is just the beginning. I expect IMM to be the best performing share of 2018.

[che7win] 04/12/2017 09:31

Very close to breaking out here.

[divmad] 04/12/2017 09:05

30p on negative results.

[kensingtoncourt] 04/12/2017 08:47

Being eyed up by quite a few large pharmas I expect. We will have the long awaited news soon enough.

[ewads] 04/12/2017 08:37

See a lot of my filtered trolls are up early today. Big push for investors?

[ballsac] 04/12/2017 08:28

It'll be more like £200+ if Lupuzor can treat all those diseases as expected. The RA market alone is eight or nine times the size of lupus.

[ny boy] 04/12/2017 08:26

All released data to date suggests this could be a big one, certainly a gamble like all stocks but you sense a more calculated gamble, interest will highten as we approach January onwards.

Looks like an exciting ride ahead, certainly dips are quickly bought, who wants to be out as the share price slowly moves higher each week.

The potential returns could be spectacular, you maybe correct money maker1

[flavio_monteiro] 04/12/2017 08:22

Top tips...you must be loaded with your daily top ups. 😊

[money maker1] 04/12/2017 08:21

£60 to £100 on positive results.

[money maker1] 04/12/2017 08:19

Are you getting excited TT?

[top tips] 04/12/2017 08:11

Cheeky little top up this could take off any day now.

[englishlongbow] 04/12/2017 08:00

IMM could be the once in a lifetime opportunity to get into something really big.

[top tips] 04/12/2017 06:35

Evidence so far is that Lupuzor will be a great success in treating not just lupus but more than a dozen other indications making it one of the most commercially valuable drugs on the market.

[top tips] 04/12/2017 06:32

I think we might get the results in January.

[immy1992] 04/12/2017 05:47

Ooh we're back on the accelerated approval topic.

Longterm, your link ( hxxps://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072063.pdf ) is from May 2010. Whilst it may be specifically mentioning SLE i believe the FDA's stance on a lot of things has changed significantly since then. I believe that these days Accelerated approval is being granted based on surrogate endpoints or clinical end points as well.

I found this Guidance from 2014 to be quite useful and more updated
hxxps://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf

VII. ACCELERATED APPROVAL
The accelerated approval provisions of FDASIA in section 506(c) of the FD&C Act provide that
FDA may grant accelerated approval to:
. . . a product for a serious or life-threatening disease or condition . . . upon a
determination that the product has an effect on a surrogate endpoint that is reasonably
likely to predict clinical benefit, or ON A CLINICAL ENDPOINT that can be measured earlier
than irreversible morbidity or mortality, that is reasonably likely to predict an effect on
irreversible morbidity or mortality or other clinical benefit, taking into account the
severity, rarity, or prevalence of the condition and the availability or lack of alternative
treatments. "

B. Accelerated Approval Endpoints
The two types of endpoints that can be used as a basis for accelerated approval are: (1) a
surrogate endpoint that is considered reasonably likely to predict clinical benefit and (2) a
clinical endpoint that can be measured earlier than IMM that is reasonably likely to predict an
effect on IMM or other clinical benefit (also see section VII.D.2.). For purposes of this
guidance, these categories of endpoints are referred to as surrogate endpoints and intermediate
clinical endpoints, respectively.
A clinical endpoint is a characteristic or variable that directly measures a therapeutic effect of a
drug––an effect on how a patient feels (e.g., symptom relief), functions (e.g., improved
mobility), or survives.
A clinical benefit is a positive therapeutic effect that is clinically meaningful in the context of a
given disease. The clinical benefit must be weighed against a treatment’s risks to determine
whether there is an overall benefit for patients (i.e., a positive benefit-risk profile).

FDA believes the new
provisions provide additional flexibility concerning the implications of available therapy on
eligibility for accelerated approval (see section VII.A.2.). They also provide clarification
concerning the use of clinical endpoints (herein referred to as intermediate clinical endpoints) as
a basis for accelerated approval (see section VII.B.2.). In addition, the new provisions make
clear that FDA has the authority to consider pharmacologic or other evidence developed using
biomarkers or other scientific methods or tools, in conjunction with other data, in determining
whether an endpoint is reasonably likely to predict clinical benefit (see section VII.C.).17

I'd just like add a few words regarding the terminology of it all. From my belief, IMM has been given FAST TRACK designation programme status under the Special Protocol assesment act.However having that Fast track designation status under the SPA, allows IMM the option of discussing accelerated approval/ prioprity review based on some efficacy claim should ph3 turn out to be good. Also worth mentioning that tim has been saying in many interviews and presentations that they are in talks with the relevant authorities

B. Features of Fast Track Designation
1. Actions to Expedite Development and Review
There are opportunities for frequent interactions with the review team for a fast track product.
These include meetings with FDA, including pre-IND meetings, end-of-phase 1 meetings, and
end-of-phase 2 meetings to discuss study design, extent of safety data required to support
approval, dose-response concerns, and use of biomarkers. Other meetings may be scheduled as
appropriate (e.g., to discuss accelerated approval, the structure and content of an NDA, and other
critical issues).
In addition, such a product could be eligible for priority review if supported by clinical data at
the time of BLA, NDA, or efficacy supplement submission (see section VIII).

At the end of the day their SPA has set out 2x200 trials . I believe they are conducting 1 now with the hopes of getting a strong efficacy and safety claim, and then they are going to go to the FDA and ask for accelerated approval or a priority review which gets them a response within 6 months. If granted accelerated approval the 2nd trial will be run a confirmatory trial whilst the drug is in the market.

2. Confirmatory Trials
For drugs granted accelerated approval, postmarketing confirmatory trials have been required to
verify and describe the anticipated effect on IMM or other clinical benefit. These trials must be
completed with due diligence.31

VIII. PRIORITY REVIEW DESIGNATION
An application for a drug will receive priority review designation if it is for a drug that treats a
serious condition and, if approved, would provide a significant improvement in safety or
effectiveness. In addition, specific statutory provisions provide for priority review for various
types of applications, described in section IV. A priority designation is intended to direct overall
attention and resources to the evaluation of such applications. This section describes the
qualifying criteria and the features of priority review designation. Appendix 1 describes the
process for priority review designation.


Whichever route IMM choose to pursue it is clear that they are all in and are expecting good things from this 1 phase 3 trial and are going to be going back to FDA with some sort of expedited requet ( i believe tim said this to someone during the proactive investors conference too). It is highly likely that the 2nd phase 3 trial will run however i believe it will be more of a phase 4/ confirmatory type thing.

That is all based on the key assumption here that the results are going to be superior then benlysta's at the very least, of course. I guess in two-three months time, we will know

[alphapig] 04/12/2017 00:52

Windjammer, so now I understand why only one phase iii trial, you could have posted that some time ago?

[ny boy] 03/12/2017 18:40

Tim said at a recent investor meeting, they had enough funds to take them through to next year, so it’s not an issue.

[l0ngterm] 03/12/2017 18:37

W1nd: watched the video, and it maybe my hangover so bear with me, but can you clarify further what you were referring to?Was it the statement of a phase III 200 trial? As this seems to contradict the amended spa which was 2 x 200 trials. which I believe is causing the confusion here.Or did I completely miss something?

[kensingtoncourt] 03/12/2017 12:35

They staged a fundraising in 2017 to raise enough cash to get through 2018 so allowing them to negotiate a deal, sale or takeover following Lupuzor results, from a position of strength.

[hamhamham1] 03/12/2017 12:11

W1. Many thanks for the link. Good watch. Did they say in that video that they had enough cash in the bank to last until end of 2018? If so, that's good.

[w1ndjammer] 03/12/2017 10:03

Their was a lot of nonsense posted yesterday about having to run a second trial
if you watch this video from 10 minutes you will hear about the fast track from
the horses mouth.



WJ.

[ny boy] 02/12/2017 22:58

Nothing to talk about until end of January, slow grind north to 150p+ this month, leading to frantic buying mid January onwards

[supernumerary] 02/12/2017 19:39

1ret - you can't put less than and greater than signs in posts - advfn treats them as HTML. Just write them out in full if you need them.

[hamhamham1] 02/12/2017 19:12

I don't think I can send PMs (have a free basic account).