Anyone understands this statement re - Lorcaserin on the EMA website
Decision type: P: decision agreeing on a Paediatric Investigation Plan, with or without partial waiver(s) and or deferral(s)
Sentiment: Strong Buy
Here is the explanation -
A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of a medicine for children. Pharmaceutical companies submit proposals for PIPs to the European Medicines Agency's Paediatric Committee (PDCO). This Committee is responsible for agreeing or refusing the plan.
The Paediatric Regulation requires PIPs to be submitted to the Agency early, wherever possible.
The normal development of a medicine requires that various studies be performed to ensure its quality, safety and efficacy. PIPs:
include a description of the studies and of the measures to adapt the medicine's formulation to make its use more acceptable in children, such as use of a liquid formulation rather than large tablets;
cover the needs of all age groups of children, from birth to adolescence;
define the timing of studies in children compared to adults.
The development plan for a medicine can be modified at a later stage as knowledge increases. Modifications can also be made if the applicant encounters such difficulties with the implementation of a PIP, which render it unworkable or no longer appropriate.
In some cases, studies can be deferred until after the studies in adults have been conducted. This ensures that research in children is done only when it is safe and ethical to do so. Even when studies are deferred, the PIP will include details of the paediatric studies and their timelines.
As some diseases do not affect children (for example Parkinson's disease), the development of medicines for these diseases should not be performed in children. In these cases, a PIP is not required and it will be waived. For more information on the classes of diseases subject to waivers, see class waivers.
Sentiment: Strong Buy
Thank for confirming what all the longs are expecting since last January meeting! Since ARNA answered all the additional questions CHAMP has there's a good chance that the lorcaserin's decision will be positive. There's a good chance that the lorcaserin will be approved in Europe tomorrow before it the DEA finalizes the schedule!!!!!!!!
Do you know if there was an Oral Explanation Monday or yesterday?
If what you are saying is true, then an opinion was already adopted this morning, and the outcome will be faxed to ARNA in few hours (London time). The CHMP Press Release will be created by Press Office and published today and posted to the website Friday morning. Possible outcomes:
1) Positive in which case we will know tomorrow morning
2) A second list of outstanding issues in which case we will know next Tuesday thru SEC Form-8k by ARNA
3) I do not want to say it, in which case we will also know tomorrow morning.
Sentiment: Strong Buy
But if it wasn't covered in this weeks agenda we won't know anything tomorrow or Tuesday. Presumably we will at least see it on the docket for tomorrow in the register - right? So if we see no mention of it at all, then it slides to next month.
Tiger, if ARNA presented at this meeting, then the clock won't start running until May 1 (which would be Day 181); and the opinion won't be adopted until the May meeting.
I think - think - they presented in March and the clock restarted on March 28 (as per the timetable); it is also possible that the oral presentation request was dropped at the March meeting with the same effect; the clock restarting on March 28. This also is consistent with lorcaserin's second appearance on the PRAC agenda occurring earlier this month.
See page 11/12 of the full application timetable.
An empty roll of toilet paper...funny...Much like your comments...Europe time huh?...haven't seen anything noteworthy in any of your comments...however, day traders are allowed...but you will lose in the long run...As if you care....
LuckyCharm ... you probably had the best of intentions when you made this post. But unfortunately there are a lot of frustrated people here who are fed up of hearsay information.
I think this one was pretty dumb -- CHMP meeting is still in progress and there is no way of knowing what will be the outcome.
If I were you, I would just refrain from making some comments, and hold it back for just 2 more days ... or early next week.
Even if something good comes out of this meeting, it will only be a recommendation not a final decision for Europe
Do you think I don't know that? But usually in most cases, the final decision is the same as the one recommended by chmp! Lets keep our fingers crossed! It was an opinion, If people are fed up than its not my problem. They're prolly fed up because of all these bashers and pumpers who post every 2 seconds everyday! The iggy button is the best