The company needs to give some guidance before the stock can make a move to a new level. Investors are in the dark whether the recent data was adequate to move the program forward or will they have to fine tune the strip further before advancing. They were supposed to meet with the FDA, hire a new CSO, & conduct a trial on the highest dosage, before proceeding to the Phase III trials. There's also the question on the next cash raise.

How can the stock advance without knowing if we're 2 or 4yrs away from filing the NDA?

We should get the 4th qtr earning release in the next few weeks. I imagine management will include an update on the clinical development plans going forward.

How did you get that info? I follow him & didn't see the tweet. That's about the best reason investors could have gotten for the CSO leaving.

Dew, I tried to do a I-hub search for companies which got a CRL after a positive adcom but didn't come up with any results. Has a list ever been compiled on this board?

He's staying at the company until they find a replacement which is a positive. If he had screwed something up then they would have just told him to hit the road.

Yes, I've had a lot of experience with crowd funding.

Send your funds to:

John Smith
P.O BOX 1111
Havana Cuba 89701

P.s. I accept gold, bitcoins, & cash

DRRX - The clinical studies showed mixed efficacy but the same could be said for some of PCRX's. Its my understanding DRRX filed the NDA knowing the FDA would probably give them a CRL. The thinking was #1 you might get lucky & get approved or #2 the CRL would give guidance on what the FDA would like to see in order to approve.

I'm basically saying it may not be a good idea to hold a position thru approval.

I've always thought cost would be the biggest hurdle however the same thing was true when the pen was introduced to the insulin market. Individuals that are used to injecting themselves will probably be slow to transition to an injector but once you use the injector then your not going back to the old method.

I talked to Howarth about this issue previously. His defense was that the injector would have minimal additional costs since insurance was picking up most of the tab. In addition, most individuals wouldn't object to the additional out of pocket expense due to the convenience factor.

The individuals in the blog had not checked on the added cost or tried the injector.

The dopaminergic receptors are down regulated in advanced Parkinson patients so that's why they can tolerate high dose apomorphine but normal individuals experience a number of side effects with higher doses.

The new presentation slides

http://www.cynapsus.ca/melonhead/media/1389649236.pdf

CTH - 103
Slide 9 compares the 10mg strip vs 2mg SQ

The time in which it takes to reach an efficacious blood level & the time before it falls below that level is comparable between the SQ & sublingual formulations. The SQ has a higher peak blood concentration but that's not as important as the time both spend within the therapeutic range.

Slide 10 compares 15mg strip vs 3mg SQ

The time under the curve are comparable with the sublingual actually exceeding the range in which the SQ spends within the therapeutic window. The SQ also peaks at a toxic level which increases the chances for side effects.

The planned highest dose was not administered to the healthy individuals since they are more sensitive to the drug then Parkinson's patients.

Summary: The sublingual looks like its a better treatment option. More convenient, less side effects, & potentially longer acting.

Dude, your mixed up.

TEVA sells Copaxone which treats multiple sclerosis. It does not look like ATRS will supply the injector for 3 X week.

ATRS - (Otrexup) Methotrexate treats rheumatoid arthritis

The last raise was supposed to speed up the pipeline development. The most important thing is securing the patents for any drug developments so I can live with a slow process.

I looking at AVNR yesterday & its a rip off how fast generic competitors can try & challenge the patents. Generics try to enter the market before companies have recouped their development costs or turned profitable in some instances.

Does anyone think raising a few dollars would be a good idea? The more cash a companies got in the bank the better as far as I'm concerned. I'd like to see them raise another $40 million.

The stock is trading like the China deal fell through. It doesn't surprise me they would get denied since companies probably have a minimum capital requirement to do business there.

Why pay .1199 - .12's when the stock going to be trading at .09's next week?

This might be the first company I've ever seen release a PR to say they've updated the Website with a Q & A section, LMAO.

Yea, I can see the 18 wheelers loading up at the dock. LMAO.

OMG, that made my day. I was giving the company to much credit when I said it was probably operated out of a garage. It looks like a $100 a month store front in a small strip center in back woods Tennessee.

I think they overpaid.

Flyersdh, how much did Scrips pay WRx for the 20% ownership interest? Is this just some distributorship out a garage with one guy packaging orders with a roll of cellophane.

Yep, 20% of the profits is better then 50%. I see your learning the game.

Good Luck

They own 20% of WRx

d442125, Lets look at the most recent press release.

" ScripsAmerica Inc. (SCRC), today announced that the Company has received and processed a record high $51,920 in orders during the week ending December 13, 2013 and $84,821 in orders for the first two weeks of the month from its recent pharmaceutical distribution joint venture."

Ok, do you know what these numbers really mean?

What happens is that a small pharmacy places an order for some OTC meds. ScripsAmerica has partnered with WRX to supply these meds. The meds are stored at a distribution facility where the large lots are broken down into the smaller orders & shipped out.

Scrips is reporting the orders but what income are they really generating on this order? Their getting a mark-up (12%) which their splitting with WRX. If they have $100K in orders then we're really talking about $12K that needs to be split after the expenses for storage, packaging, etc.

Posters on this board give huge revenue projections but few details. This is a pump stock where you buy low & sell when the company releases the next PR. You can make a lot of money but learn the game.

Why would you do that? I hope you plan to sell on any pop just like the rest of the longs. I wonder if SCRC's management notifies certain shareholders before each press release?

The light trading volume is not a good sign. Vendors need to get paid so they'll sell no matter if SCRC is trading for .15 or .05.

Do I have the revenues correct? SCRC's income is really just a mark-up on sales but they claim the entire amount as revenues in their PR's. Is that correct?

So if you have revenues of $1 million you can claim that amount, but in truth its more like 1/10th of that number.

The low shares count is forcing new investors to pay the man to get in. Shares are scarce.

This is still an undiscovered play since no catalyst is surrounding the move up. Lots of room to run to the upside with any corporate update on the pipeline.

SYN - nice move this morning. This one has legs in 2014.

Nice article, gives potential investors a nice start in understanding the pipeline. No pump, just facts which is all this stock needs to get noticed.

yea,

In March 2010, we entered into a product development, manufacturing, and supply agreement with Marlex Pharmaceuticals for a pain relief 80mg orally disintegrating rapid dissolve tablets under which the pharmaceutical company will develop and supply the product, while we will fund all development costs and retain all ownership rights in the pain relief rapidly dissolving drug formulation.

If your going to combine a OTC drug like acetaminophen with a dissolving technology then you have to do testing to ensure that what your selling into the market is the therapeutic equivalent to the comparator. 80 mg of acetaminophen by tablet, syrup, dissolving tablet, etc. need to have the same blood concentrations. This is very important in pediatric patients since the therapeutic window is narrow & you could administer a toxic dose.

The first thing a company does is meet with the FDA to discuss a plan for development. Once this is done then they could do all the testing & file for approval within 3 yrs.

This would be a 505(b)(2) filing instead of an ANDA filing which actually speeds the review process to about a year.

In the best case scenario is would take 4 yrs but probably closer to 5. If any of these step were being made then I'm sure SCRC would have released numerous press releases on the progress.

There is also a good chance another manufacturer would file a patent challenge on this product which automatically delays market entry for another 30 months.

Did you tell investors that SCRC can't sell any Rapimed products in the US until they do clinical testing & file for FDA approval & that SCRC doesn't have the financing to do this?

"new investors realizing the potential of SCRC combined have purchased millions of shares."

That's true, but why does the stock keep going down? Could it be that there are millions of shares that need to find a home in the hands of new suckers?

I haven't started posting about the financing yet. All in due time. He who laughs last laughs best.

"Scrips doesn't manufacture rapimeds therefore no anda, refer to capricorn."

That's correct but someone still has to do the necessary clinical work & applications that's never been done.

I guess you think any company can combine acetaminophen with the rapid melt technology & put it on the market without going through the necessary approval procedures?

They have certain testing standards for OTC products or new formulations of OTC products.

Do you not think I know how the FDA approves OTC drugs?

My question is how SCRC plans to sell this drug if its never been FDA approved?

Thank you, that's what I thought.

Is ScripsAmerica as concerned as you about the pediatric population is my question?

Is Rapidmelt an FDA approved product?

I posted a simple question. Any investor on this board should be able to answer it.

The FDA is very concerned about any drugs marketed to the pediatric population so I just wanted to know when the application for the product was approved.

I'm trying to do some research on this company.

"In March 2010, ScripsAmerica entered into a product development, manufacturing, and supply agreement for Acetaminophen 80mg and 160mg orally disintegrating rapid dissolve tablets under which its partner will develop and supply the product, while ScripsAmerica will fund all development costs and own the final product."


Can anyone tell me where the ANDA approval information is for this drug?

"ScripsAmerica obtained the exclusive rights to the manufacturers patented process for RapiMed. RapiMed is part of the Oral Delivery Technology (ODT) and what is commonly referred to as Quickmelt."

Scrips obtained the rights for the oral delivery in 2012 but had any work previously been done to gain FDA approval for acetaminophen using this technology?