Motif Bio Share Discussion Threads

[buywell3] 19/5/2019 18:06

As buywell said a while back this drug combo means a whole new start

Back to Pre Clinical studies and make sure you include transporter assays data in your submission

Motif Bio, Lamellar Agree to Test New Therapeutic Combo for CF Lung Infections

[carlsagan1] 19/5/2019 17:11

ii will be increasing fees again from June 10th - £9.99 a month from £22.50 a quarter

Any recommendations for a cheaper broker? long overdue that I go elsewhere.

I am considering going to iweb-sharedealing(Halifax) for a fixed £5 a trade or X-O(Jarvis) for £5.95, neither have monthly, yearly, or inactivity fees like ii...

[aladin1033] 17/5/2019 14:01

Yu offer of £7.20


This is the same guy on twitter that got the iog offer right for 20p no reason to doubt him

[gersemi] 15/5/2019 20:16

Four announcements to watch out for in May and June

By Andrew Hore - 13/05/2019

Here are four events to look out for in May and June. Motif Bio, Pressure Technologies, TechFinancials and Mereo Biopharma are all set to make announcements that could have a significant effect on each individual share price.

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Motif Bio (LON: MTFB)

Motif Bio had high hopes for its Iclaprim treatment for acute bacterial skin and skin structure infections. However, these hopes were severely dented. The result of a meeting with the FDA will be significant to getting back on track and a recovery in the share price.

The complete response letter from the US FDA was received in February. Motif had hoped that this would enable approval of Iclaprim, but the regulator said it could not approve the new drug application (NDA) in its current form. Concerns about liver toxicity were highlighted.

Motif has met with the FDA in order to discuss the points raised by the regulator. By the end of this month or early June, Motif should receive the minutes of the meeting.

This will be key to any decision on how Motif can progress with Iclaprim, if at all. Ideally, the meeting will provide a path to marketing approval for Iclaprim. Ten years of exclusivity in the US is available if approval is gained.

In March, Motif raised £2.7m at 6p a share and this cash funds the company into June. Further cash will be required, and the amount needed, and whether it can be raised, will depend on the minutes.

Positive news from the FDA could make the share price bounce back and make it easier to raise cash.

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[newtothisgame3] 14/5/2019 10:38

Motif Bio, Lamellar Agree to Test New Therapeutic Combo for CF Lung Infections

[newtothisgame3] 14/5/2019 10:38

Motif Bio, Lamellar Agree to Test New Therapeutic Combo for CF Lung Infections

[newtothisgame3] 14/5/2019 10:23

Four announcements to watch out for in May and June
By Andrew Hore - 13/05/2019

[newtothisgame3] 14/5/2019 10:23

Four announcements to watch out for in May and June
By Andrew Hore - 13/05/2019

[gersemi] 10/5/2019 07:00

'We don’t believe that any additional clinical trials will be required, however we will be unsure of a timeline regarding resubmission of the NDA until after the company’s meeting with the FDA. '

[ivyspivey] 09/5/2019 21:25

Hi Andrews need to make it capital H for it to work as a link

[ivyspivey] 09/5/2019 21:24

FYI New Corporate Presentation

[andrewsr] 09/5/2019 18:50

Thanks to Ian B on LSE:
hxxps://audioboom.com/posts/7256254-chariot-oil-gas-vadim-alexandre-on-motif-bio-plus-chris-bailey-on-bt-superdry-and-barratt-dev

[rapidlyprogressing] 08/5/2019 17:16

Grrrr. Bottom draw for a bit it is then!

[volsung] 08/5/2019 15:29

Famous last words :(

[rapidlyprogressing] 05/5/2019 15:31

Hoping to make an attack on 10p again on Tuesday!

[gersemi] 04/5/2019 13:38

'Type A meetings—These are urgent or • critical meetings primarily to resolve safety and clinical hold issues. Typically, they are convened for quick resolution of issues, such as reports of an adverse event, that could affect the safety of study participants and lead to an interim or permanent halt to an ongoing clinical trial. In addition, Type A meetings can be requested for resolu-tion of disputes between the reviewers and sponsors or for special protocol assessment'

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Note the line 'Typically, they are convened for quick resolution of issues, such as reports of an adverse event, that could affect the safety of study participants'......this is interesting which may explain why the market remains reasonably positive though as always we await confirmed news from FDA and MTFB



This link is superb insight into Type meetings procedures

[ivyspivey] 04/5/2019 13:33

Absolutely Andrews- the collaboration has nothing to do with any issues with Iclaprim and ABSSSI.
Anyway the efficacy of Iclaprim was not questioned just some specific issues on possible liver toxicity.

[andrewsr] 04/5/2019 11:30

buywell,
The collaboration with Lamellar is nothing to do with the ABSSSI treatment and yesterday's meeting. The combined treatment with Lamellar is only for Cystic Fibrosis.

[bountyhunter] 04/5/2019 09:44

Exactly, and I think we can be confident that MTFB will have mentioned the date of the AGM at the meeting so it's not unreasonable to think there will be a good chance that the minutes will be released by then. Clearly it will be a more meaningful AGM if that is the case where we can all move on to consider the next stage sooner rather than later whatever that may be.

[gersemi] 04/5/2019 09:40

'The FDA will issue the official, finalized minutes to the requester within 30 calendar days after the meeting'

Note the word 'within'. The time-frame is not strictly 30 days.

[gersemi] 04/5/2019 09:34

It's important to note that the FDA could have denied MTFB a meeting of any kind. You have to apply to the FDA for a 'type' (A, B or C) meeting and the FDA then considers a response. A meeting is not automatic. if the FDA believes there's nothing to be gained from a meeting then a meeting will simply not be granted. MTFB were AWARDED a Type A meeting following the company's request. The FDA could have easily denied Motif a meeting and that would have killed the company. There's real hope here. The drug works, It's been proven to work. The trials to date have shown it works without serious side-effects. The FDA knows Iclaprim works. The way forward? Well, we shall see the response from the FDA but the fact that a meetingt's been awarded is a positive in itself

read this -

'A. Meeting Denied

'If a meeting request is denied, the FDA will notify the requester in writing according to the timelines described in Table 1. The FDA’s letter will include an explanation of the reason for the denial. Denials will be based on a substantive reason, not merely on the absence of a minor element of the meeting request or meeting package items. For example, a meeting can be denied because it is premature for the stage of product development or because the meeting package does not provide an adequate basis for the meeting discussion'

B. Meeting Granted
If a meeting request is granted, the FDA will notify the requester in writing according to the timelines described in Table 1.

-- Note 'Meeting granted'

[buywell3] 04/5/2019 08:53

I am sure the BOD know by what was asked and talked about that the FDA are not going to change their previous opinions on this compound.

Hence the proposed mix with another drug to try get another chance as it where ... BUT you can't do that without extra testing because of unknown effects happening.




I have some experience in the ADMET area ... newbes read up on this before you press the BUY button.

buywell never posts without having researched what he says .... apologies will be considered





Drug-Drug Interaction.

A change in a drug's effect on the body when the drug is taken together with a second drug.
This can decrease or increase the action of either or both drugs or cause adverse effects.


Drug Development and Drug Interactions - FDA



Overview.

Drug-drug interactions can lead to changed systemic exposure, resulting in variations in drug response of the co-administered drugs. ... This Web site provides drug developers with FDA's current understanding of how to conduct drug-interaction studies and resulting labeling.


In conclusion IMO the FDA would want at a minimum fresh new clinical trials on the new 'MIX' compound

even IF the transporter testing results came out OK.

$20M to $30M needed

dyor
it pays