Member Info for Jimmybob

Where you guys getting this from? NDA submitted already, CRL issued and meeting planned to address why this cannot be approved in its current form. Why do you think this needs a new NDA many drugs have been approved on the back of an initial CRL? JB

No one will know the result of the meeting until June. People are wrongly assuming 3rd of May and all will be reviewed it does work like that the Agency will take a month to come back with their decision. JB

Customer and shareholder relations manger would be a great start. This has been going on too long. Losing faith;-(. JB

Never thought I would get another lot under 20p in my isa;-). JB

Yes a one trick pony, think the EMA application is on hold, no funds & the strategy is to go to FDA first. Have complete the agreed FDA trials endpoints seem successful. CRL is a surprise, need extra data on liver toxicity risk. Could either need a label warning to address or perhaps more data. More data might be as simple as pulling a subset of study subjects in from the exhausting trials for further follow up i.e a blood test/scan so may not be that big a deal. But we don’t know. I am in and holing until post FDA meeting, resubmission and hopefully approval. Risk vs reward seems palitable at these very low prices. JB

The company won’t say a thing until after the FDA meeting. They are doing the right thing and do want to owe off the Agency. JB

So, let’s all get pissed while we wait for real news then? That wine cellar open;-) how you doing all recovered? JB

60p I would definitely take that! 0.6p is a bargain;-). JB

Hang in there BB the end is near hopefully! JB

We now have an optimised dose and formulation so this history is somewhat irrelevant as the issues have been addressed. JB

Guys, we are all pointing the fingers at CF here for a hang over yet our volumes are so small. Makes it so easy to manipulate the price. We need news and this will fly but I am starting to think, CF is not the current reason we are here, it’s market sentiment. Let hope news moves us to where we should be. The management team seem to be taking every opportunity to promote the value we have. I am a bit flummoxed on what is holding us back. Ps I am balls deep at an average of 0.78 so not derailing. The value will tell through in the end just need some worthy news to help us take off! JB

Agree completely Paul over promising and under delivering completely undermines confidence. He needs to get this back on track ASAP. I am a believer here and hopefully did the right thing in averaging down recently. Still sitting on a significant loss though. Good luck to all there is so much potential here and the great thing is the company has been successfully proving up and selling gas. JB

https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2013/1/study-shows-impact-of-complete-response-letters-on-approval-times a bit out of dates but worth a read. JB

Surprised we have moved up so well and thdvrises is holding up, the AMP sellers/overhang must be being absorbed which is a good sign. JB

Exactly! JB

PhD with 25 years in product development in Healthcare. Been to the Agency many times for product approvals. Mainly med devices, some combo products and BLAs, no NDAs though. JB

You are an expert and deal with the Agency everyday? You seem to have a different experience than me when dealing with applications. JB

The FDA have sent timelines and rearly shorten them for anyone. In this climate I would suggest that the timeline given is actually very positive and the FDA must see this as a prioroty. JB

I think your are missing the point, this is probably the start of the discussion rather than, as you are indicating, it’s completed and there is no further dialog and we are all doomed;-) JB

I am actually a Dr (PhD) and work in Medical device development, I actually know n4p as he worked with me to develop a post market survelience tracking system for medical devices. It is very common for the FDA to ask safety questions and for company’s to bring in experts and key opinion leaders to try and address concerns. These are only likely to be resolved by the face to face review. I disagree that the conversations are over I would suggest that they are in progress and the process will get resolved at the review. Good luck all! JB